Penis Surgery

5 questions to ask before having penis surgery

By Elizabeth Cohen, CNN Senior Medical Correspondent August 25, 2011 7:24 a.m. EDT The penis is a highly vascularized organ, which means there’s a lot of blood running through it, so cutting into it can be risky.STORY HIGHLIGHTS Doctors urge men with erectile dysfunction to try other, less risky, treatments first For implants, also try to find a doctor who does at least two or three a month Cutting into the penis leaves you vulnerable to infection RELATED TOPICS Male Sexual Dysfunction Men’s Health Sexual and Reproductive Health Surgery (CNN) — If you’re a woman contemplating surgery on your female parts, you’ll find plenty of ladies chatting and blogging away about their experiences, often on websites adorned with pink ribbons. But if you’re a man considering male surgery there’s not so much out there. There’s no ribbon for, say, penis surgery, and comparatively few men trading stories and sharing advice. “Women are much more engaged with their health,” says Dr. Dennis Pessis, president-elect of the American Urological Association. “It’s gotten better in the past 15 years, but still, men don’t always seek out the best treatments for themselves.” Penis surgery has been in the spotlight this week as a civil trial in Kentucky made national headlines. Phillip Seaton, a Kentucky truck driver, sued his urologist, Dr. John Patterson, saying he went in for a circumcision but left the surgery with part of his penis amputated. Patterson says Seaton had cancer and needed the amputation or he would have died. The doctor won the case on Wednesday, according to CNN affiliate WDRB. Seaton’s experience is certainly rare, surgery on the penis isn’t. While good statistics are hard to find, tens of thousands of men in the United States get circumcised as adults. Other common surgeries include implants for men suffering erectile dysfunction and removal of genital warts. Here’s the Empowered Patient list of questions every man should ask before having these procedures on this most valued and delicate of organs. 1. Do I really need this procedure? Think twice (or more) before having the surgery. It’s a highly vascularized organ, which is a fancy way of saying there is a lot of blood running in and out of it, so cutting into it can be risky. Men getting circumcised as adults should consider the risk of bleeding, especially if they’re on a blood thinner, including aspirin. Getting implants requires cutting, too, and doctors urge men with erectile dysfunction to try other, less risky, treatments first, such as drugs like Viagra, penile injections, or a penis pump, an external device that fits over the organ. You’ll also need to choose what kind of anesthesia you’ll want for your circumcision. You can opt for a local anesthetic and a sedative — you’ll be (or should be) relaxed but awake. Men who are especially anxious about the surgery often opt for general anesthesia, which is slightly more risky but ensures they’ll be totally out for the procedure. As for genital warts, if a man is not experiencing problems such as itching, burning or pain, he may not need treatment, according to the Mayo Clinic. 2. What are my treatment options? There is more than one type of penile implant and there is more than one way to remove genital warts. Doctors tend to specialize in one method over the other, so make sure your doctor lays out all the options and refers you to another doctor who can perform the procedure the way you prefer. There are two types of implants. With inflatable implants, doctors put cylinders inside the penis, a pump in the scrotum, and a fluid reserve inside either the scrotum or the abdominal wall. Before sex, you pump the fluid into the cylinders to create an erection. After sex, you activate a release valve in the scrotum to let the fluid out. The second type of implant involves putting semi-rigid rods into the penis, and it is bent away from the body to have sex (think of it as a goose-necked desk lamp that can be pointed in various directions). For more on various types of penile implants, see information from the Mayo Clinic and the American Urological Association. For warts, you can treat them yourself or your doctor can treat them. If you choose the DIY approach, your doctor prescribes a medicine for you to apply at home. If you prefer to have your doctor treat the warts, there are several options: Your doctor can apply a medicine, which is sometimes a stronger version of what you can apply at home. There is also an option to cauterize or laser the warts, or to freeze them off with liquid nitrogen. “You should give yourself some time to make the right decision,” says Dr. Gopal Badlani, a urologist at Wake Forest Baptist Medical Center. “You don’t want to decide at the first appointment.” For more information on the various options for removing genital warts, see information from the Centers for Disease Control and Prevention. 3. Doctor, how many of these procedures have you done? Look for a urologist who regularly performs the procedure you need. “Some urologists do nothing but treat kidney stones or urinary incontinence, and you don’t want that urologist doing your circumcision,” says Dr. Irwin Goldstein, director of San Diego Sexual Medicine. “They need to know what they’re doing so they don’t remove too much or too little skin, or create a new problem like an angled penis.” While there’s no magic number, Goldstein says if you’re having a circumcision, find someone who does at least two or three a month. Plus, you should ask the doctor for names of his or her previous circumcision patients. “It’s sort of like fixing your roof — you want to talk to a client who’s used that roofer,” he advises. “Ask about the doctor’s follow-up: Was he available, or did he just do the surgery and you didn’t hear from him again?” For implants, also try to find a doctor who does at least two or three a month, Goldstein advises, not someone who just dabbles in the procedure. “We did three implants Monday, just to give you a sense of how often some doctors do these,” Goldstein adds. The removal of genital warts isn’t as complicated as circumcision or implant surgery, but still make sure it’s something your doctor does regularly. 4. Will the treatment really cure my problem? Badlani says no matter how much he counsels his patients before implant surgery, most are disappointed the implants didn’t give them as large an erection as they had when they were 18. “Ninety-five percent of the time, after the surgery the patient feels shortchanged. They say, ‘Doc, I expected it to be much longer,’ ” Badlani says. “Men need to have more realistic expectations.” Men are also sometimes surprised that their genital warts come back after treatment. But the Mayo Clinic says genital warts “are likely to recur” because even after you remove them, you still carry the virus that causes warts, called the human papillomavirus (HPV). 5. Should I clean up before the surgery? Cutting into the penis leaves you vulnerable to infection, so ask your doctor if you should be scrubbing at home before surgery day. Goldstein tells his circumcision patients to clean with a special antiseptic once a day for three days before the surgery. He has his implant patients wash up morning and night for seven days before surgery, and take antibiotics for three days before. “We’re inserting a foreign body into the penis. The chances for things to go wrong are magnified, so we want to take all precautions,” he says. CNN’s Sabriya Rice contributed to this report.

PSA Screening

Change Screening Attitudes, Cancer Researcher Says

By Nancy Walsh, Staff Writer, MedPage Today
Published: November 25, 2011
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
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Action Points


    • A researcher believes that the time has come for a fundamental shift in attitude toward cancer screening, with greater emphasis on providing the public with information about absolute risks and the potential for harm associated with screening.
  • It was recommended that patients and the public should be given clear information — based on science rather than opinion or advocacy — that explains cancer incidence and mortality, and provides transparent information about the risks and benefits of screening.

The time has come for a fundamental shift in attitude toward cancer screening, with greater emphasis on providing the public with information about absolute risks and the potential for harm associated with screening, according to a behavioral oncology researcher.

The firestorm that erupted after the U.S. Preventive Services Task Force recommended against mammograms for women ages 40 to 49 was emblematic of the controversies generated among healthcare providers, the public, and advocacy groups every time new guidelines are announced, according to Michael Edward Stefanek, PhD, of Indiana University in Bloomington.

A perspective that is unappreciated is that at least 1,900 women in their 40s would need to undergo mammography to avoid one death over 11 years. During that follow-up time, there would be 2,000 false-positive tests, “along with the resulting unnecessary biopsies, overdiagnosis, and overtreatment,” Stefanek explained in a commentary in the December 20 issue of the Journal of the National Cancer Institute.

Even routine mammography for women ages 50 to 70 — a recommendation that has not been seen as controversial — has considerable opportunity for harm, with 838 women having to be screened during six years to prevent a single death from breast cancer.

And among women in their 50s, five in 1,000 can be expected to succumb to breast cancer during a ten-year period, but annual screening during that time would only prevent one of those five deaths. Nearly 1,000 women “screened for ten years will have gained nothing, and may have been subject to as many as 50% false-positive tests, unnecessary biopsies, overdiagnosis, and overtreatment for breast cancer,” he argued.

The public has not been well served by policy makers and institutions that have taken the approach of emphasizing the benefits of cancer screening, particularly in reducing mortality, and downplaying the consequences, particularly of unnecessary treatments, he stated.

“There will come a time when all the patients have been followed, all the analyses done, all the groups assembled, and all the editorials written, and we still will not be secure in our knowledge of the individual harms and benefits of cancer screening. It appears that this time has come,” wrote Stefanek, who has previously held positions at the National Cancer Institute and the American Cancer Society.

The evidence for prostate cancer screening also is ambiguous. For instance, one study that included 20,000 men who had prostate-specific antigen (PSA) testing every two years or no screening found a decrease in deaths from prostate cancer of nearly 50% with the test over 14 years.

Yet a meta-analysis that included almost 400,000 men found no improvement in either overall mortality or prostate cancer-specific deaths.

Moreover, a randomized trial determined that 1,410 men would have to undergo screening and 48 cancers treated to prevent a single prostate cancer-related death, according to Stefanek.

And for the more recent notion of screening smokers for lung cancer using CT scans, the potential harms associated with screening have been clearly demonstrated by the finding that about 95% of positive screens were, in fact, false positives.

To address these concerns, Stefanek offered a number of possible strategies.

An important shift must emphasize the education of healthcare providers and the public, rather than encouraging a specific approach or behavior.

Patients and the public should be given clear information — based on science rather than opinion or advocacy — that explains cancer incidence and mortality, and provides transparent information about the risks and benefits of screening.

Furthermore, risks should be presented as absolute rates and in ways that can be easily understood, the researcher advised.

Another component of the new strategy would be the creation of a partnership among scientific and advocacy groups, but not to further develop and disseminate guidelines.

Rather, the task should be to develop the clearest educational materials so patients and caregivers can together make the most appropriate individual decisions on screening.

This informed decision-making approach should be accompanied by the implementation of measures that evaluate the number of patients who have been educated, rather than how many are screened.

In addition to these strategies, “and critically important, we need to energize work to identify markers that discriminate minimal-risk disease likely to have little impact on mortality versus high-risk disease,” he wrote.

Shifting screening decisions away from a public health perspective to an informed individual approach will allow consideration of factors typically overlooked, such as anxiety about illness, acceptable degrees of risk, and the negative consequences of unnecessary treatment.

Such an approach, clearly informing patients about both benefits and harms of screening “involves a fundamental respect for individuals and a tolerance for truly informed decisions even if, as individuals ourselves, we would not make the same choice,” Stefanek concluded.

Mustaches and Prostate Cancer?

‘Movember’ gets hairy, for a cause

 

By Emily Smith, CNN
updated 9:13 AM EST, Tue November 1, 2011

 

Neil Van Helden, right, proudly displays his mustache at last year's Movember event at Johnny's Hideaway in Atlanta.
Neil Van Helden, right, proudly displays his mustache at last year’s Movember event at Johnny’s Hideaway in Atlanta.

STORY HIGHLIGHTS

  • During November men grow mustaches to raise money for men’s health issues
  • Movember, a nonprofit group, lays out specific rules on how to maintain your mustache
  • Chicago, America’s most mustache-friendly city, will hold the 5th annual ‘Stache Bash

(CNN) — A word of warning: You might notice a few more unshaved upper lips proudly displayed by men in the next few weeks.

Don’t worry, it’s not males the world over being lazy. They’re actually growing that Fu Manchu for a good cause.

During Movember (the month formerly known as November), men around the globe grow mustaches (hence the name) while raising money for men’s health issues. Movember started in Australia in 2003. It has spread from down under to South Africa and Europe, and five years ago it reached American shores.

This will be the fifth year Sydney native Neil Van Helden has participated in the global charity event. Van Helden came to the United States two years ago for work and said he is just like any other guy.

Submit your Movember photos to iReport!

His reasons for joining the Movember movement are simple: “I had family members deal with prostate cancer and friends with depression issues. … There’s not a whole lot out there in terms of support for men with charities. It’s not talked about that much.”

He said men in general aren’t good at committing to regular health screenings. “We’re pretty terrible at it.”

But before you sign up and start growing a ‘mo all willy-nilly, there are rules for this sort of thing, as laid out by the nonprofit group.

First and foremost, the registered participant must start November 1 clean-shaven.

Second, you need to maintain your mustache: Grooming is key.

There are also rules pertaining to gentlemanly behavior, as well as rules preventing the mustache from touching one’s sideburns (as this is a beard) or joining the mustache’s handlebars to your chin (as this is a goatee).

The goal is to get your friends to donate money to your Movember cause, which is then donated to the Prostate Cancer Foundation, LiveStrong and other men’s health research and awareness programs.

So far Americans have raised $7.5 million for Movember. Worldwide, participants have raised $174 million, which, according to Movember, makes the group the largest nongovernment funder of prostate cancer research in the world.

According to the American Cancer Society, one in every six men will get prostate cancer during his lifetime, and one in every 36 will die from the disease. Behind lung cancer, prostate cancer is the second leading cause of cancer death in men.

Van Helden got some interesting looks when he started growing his stateside ‘stache.

“It’s a lot bigger thing in Australia. Every second guy has a mustache. Everyone applauds it,” he said.

With a chuckle, he added: “Back home, the ladies like it when you have a mustache growing in Movember. Here, not so much.”

First-time mustache grower Michael Erickson is excited about his friends’ reaction to his new facial hair. He has never grown a mustache and was prompted to join Movember by some Twitter buddies. The “marriage of social media and Movember is perfect,” said Erickson, who is actively involved in social media in his job as director of marketing for a popular restaurant group in Atlanta.

For Erickson, Movember kills two birds with one stone. “I wanted to help bring attention to men’s health issues, which is something, I believe, that doesn’t get the attention it deserves. Plus, I always wanted to try to grow a mustache.”

Like most men, he recognizes that he doesn’t go for health screenings as often as he should. “That’s another reason I’m doing this: to make a commitment to myself to take better care of my own health.”

At the end of the month, parties are held around the globe to celebrate those “who sacrificed their upper lip for the month.”

Men dress up as famous mustache-sporting characters, such as the Village People. Van Helden went as Sherlock Holmes last year– complete with tweed and his pants tucked into his socks. He likes that “everyone (there) has something in common. You’re all there for a good cause.”

‘Stache soirees have grown in popularity, prompting the fifth annual “Stache Bash,” put on by the American Mustache Institute. This year the bash will be held in Chicago, which was deemed to be America’s most mustache-friendly city.

The event also benefits LiveStrong and the Prostate Cancer Foundation. The facial hair advocacy group has been around since 1965 and touts itself as “committed to battling a demonstrated discriminatory culture against people of mustached American heritage” by “promoting the growth, care and culture of the lower nose forest.”

All jokes aside, the American Mustache Institute and Movember hope to raise awareness about an often less thought about issue, men’s health.

So, if you happen to see more mustaches in November, don’t give that person a funny look. Instead, think about donating to their hairy cause or at least be inspired to get a health screening.

Patient Testimonial

“I would like to share this patient testimonial written by my patient’s wife who underwent Green Light Laser vaporization of the prostate for enlarged prostate and holmium laser lithotripsy for bladder stones.”  David Robbins, MD

Dear Dr. Robbins – I  just wanted to take a moment to thank you for such a positive experience this past week when my husband had surgery to remove his bladder stones. We dreaded the whole thing and had postponed the inevitable long past the time when he should have dealt with it. Had we known that you and your staff would make the experience so stress-free, we would have scheduled his surgery sooner. He was up and around in no time and is feeling so much better now. We really appreciate the care and attention you showed and just wanted to make sure you knew how much that meant to us. You can be certain that we will recommend you highly in the future. Thank you!

Actos and Bladder Cancer

“Many Miami urology patients have asked me recently about the association of the diabetes drug, Actos and bladder cancer.  I have posted some info below from WebMD to provide some insight.”  David Robbins, MD

 

New Bladder Cancer Warning for Diabetes Drug Actos

FDA: Increased Risk of Bladder Cancer for Patients Taking Actos the Longest
By 
WebMD Health News
Reviewed by Louise Chang, MD

 

June 16, 2011 — The FDA has issued a new warning of increased bladder cancer risk associated with use of the diabetes drug Actos (pioglitazone).

The warning comes after a review of data from a five-year analysis of an ongoing study of Actos by the manufacturer, Takeda Pharmaceuticals.

The results show that although there was no increased risk of bladder cancer among Actos users overall, there was an increased risk of bladder cancer among those who had used the drug the longest. There was also a greater risk of bladder cancer among Actos users who had been exposed to the highest cumulative dose of the drug.

Officials say information about this risk will be added to the label of the drug as well as the patient medication guide.

FDA officials say in light of this new information, Actos should not be prescribed to people with bladder cancer or people with a history of bladder cancer.

New Warning for Actos

In September, the FDA launched a safety review of Actos after initial data from the manufacturer’s ongoing 10-year study suggested that the drug may increase the risk of bladder cancer.

The agency says it is also aware of a recent epidemiological study in France that also suggests an increased risk of bladder cancer associated with Actos. Based on this study, France has suspended use of the drug and advised not starting Actos in new patients.

Actos is part of a class of drugs known as thiazolidinediones that is used to treat type 2 diabetes. It is designed to help control blood sugar levels by increasing the body’s sensitivity to insulin.

The FDA says people currently taking Actos should continue taking it until advised otherwise by their health professional. Those who are concerned about the possible risk of bladder cancer should talk to their health care provider.

Debate about prostate tests rages

“This article from North Caroloina highlights the issues involoved in the PSA debate that continues to affect the lives of patients in Miami and around the country.” David Robbins

Debate about prostate tests rages

 
 
By: RICHARD CRAVER | Winston-Salem Journal
Published: November 19, 2011

Turning 50 proved to be a milestone for Mike Tyson not just in terms of age.

Tyson, of Winston-Salem, credits the symbolic birthday for saving his life because he chose to undergo a routine prostate-specific antigen test at that time. The test measures a specific protein released by prostate cells.

Because his PSA level was elevated for his age, Tyson underwent a biopsy that revealed prostate cancer. He had surgery in February.

He said his recovery was slow but that in August, he began feeling more like himself, particularly after participating in the Livestrong program for cancer patients and survivors at local YMCAs.

The necessity of the PSA test — and the consequences of what it might reveal — has become a significant topic at local urologist offices since October, when the U.S. Preventive Services Task Force recommended against it.

For men, prostate cancer is second only to skin cancer in frequency of cancer cases. It also is the second leading cause of death, behind lung cancer.

In 2009, health-care lobbying groups criticized the task force for recommending that most women wait until age 50 to get mammograms and then have one every two years. The American Cancer Society’s longstanding recommendation is annual screening starting at 40.

Opponents of the PSA test say it tends to lead to potential misdiagnosis and unnecessary biopsies and treatment for men, particularly for those 50 and older. They say urologists support PSA testing because it can be a significant revenue source.

After conducting five clinical PSA trials, the task force said, “There is moderate or high certainty that the service has no net benefit and that the harms outweigh the benefits.” According to a New York Times report, the task force said the test “cannot tell the difference between cancers that will and will not affect a man during his natural lifetime.”

Proponents point to examples, such as Tyson, as to why the test is pertinent.

Tyson said he’s convinced PSA testing is not only necessary but should be done sooner.

“I had no symptoms of prostate cancer,” Tyson said. “Having my wife die of bone cancer in February 2008 after fighting it valiantly for seven years, and with an 11-year-old daughter to care for, I didn’t consider anything other than surgery.

“If I had gone with the watch-and-wait approach, I might not have been checked for months, if not years, because of being 50. Who knows how much the prostate cancer could have spread in that time?”

Urologists affiliated with Forsyth and Wake Forest Baptist medical centers support the stance of the American Urological Association.

“Until there is a better widespread test for this potentially devastating disease, the task force — by disparaging the test — is doing a great disservice to the men worldwide who may benefit from the PSA test,” said Dr. Sushil Lacy, president of the association.

“It is our feeling that, when interpreted appropriately, the PSA test provides important information in the diagnosis, pre-treatment staging, or risk assessment and monitoring of prostate cancer patients.”

This issue isn’t one that affects just urologists, said Karen Richardson, a spokeswoman for Wake Forest Baptist. “Many men get their prostate cancer screenings from their primary-care physicians,” she said.

Dr. Jeremy Hubbard, a urologist at Carolina Urological Associates, said he disagrees with the task force’s recommendation because it is a sweeping declaration for a decision that is individual in nature.

“We’re concerned that some patients — and some primary physicians — may only consider the task force’s recommendations and not access all the pertinent information they may need,” Hubbard said.

In 2008, the task force recommended against PSA testing in men ages 75 or older, relying instead on the watch-and-wait approach because treating the prostate cancer for men of that age could cause more harm than the disease itself.

Hubbard said that because some prostate cancer is slow to grow, “it requires reasonable active surveillance by physician and patient.”

“Treatment recommendations for someone with prostate cancer are different for someone in their 40s and 50s compared with 60s and 70s,” he said.

The American Council on Science and Health supported the task force’s recommendations because it said tens of thousands of men have had serious complications from unnecessary prostate surgery, ranging from blood in the urine to incontinence and impotence, and even death.

Dr. Gilbert Ross of the council said a more specific test for prostate cancer is needed — one that will identify only cancer cells that are likely to develop into dangerous tumors and metastases.

“The PSA test should not continue to wreak so much havoc on people’s lives,” Ross said.

Taking more medications may raise risk of erectile dysfunction

By Jeannine Stein, Los Angeles Times / For the Booster Shots blogNovember 15, 2011, 1:42 p.m.

The more medications men take, the worse their erectile dysfunction may be, a study finds.

The British Journal of Urology reports Tuesday that men who take multiple medications may be increasing their risk for erectile dysfunction. Although some of the conditions they’re being treated for might carry an ED risk, the medication on its own may also increase the danger of erectile problems.

Researchers from Kaiser Permanente surveyed 37,712 men who were part of the California Men’s Health Study about their health and current medications. More than half the men — 57% — were taking more than three medications, and higher drug use was found among older study participants and those who were African American. Taking more medications was also linked with a higher body mass index.

Overall, 29% of men surveyed said they had experienced moderate to severe erectile dysfunction. Frequency of ED was associated with taking a larger number of medications. Among men taking up to two medications, ED prevalence was 15.9%; among men taking three to five medications it was 19.7%, among men taking six to nine medications it was 25.5% and among men taking 10 or more medications it was 30.9%.

When researchers controlled for factors that could also affect ED, such as age, diabeteshigh blood pressure and smoking, taking more medications was still associated with a greater risk of ED.

“Clinically, the findings from this study suggest that a crucial step in the evaluation of ED would be to review the current medications the patient is taking and their potential side effects,” said lead author and urologist Dr. Diana Londono in a news release. “When appropriate, decreases or changes in the amount or type of medication should be considered.”

Copyright © 2011, Los Angeles Times

Primary cryoablation for Gleason 8, 9, or 10 localized prostate cancer:

“Check out this article below about cryotherapy of the prostate.  Our Miami urologist, Dr. Amery Wirtshafter contributed many patients to this valuable study evaluating the use of cryoablation for high grade prostate cancer.”

Primary cryoablation for Gleason 8, 9, or 10 localized prostate cancer:

Biochemical and local control outcomes from the Cryo OnLine database registry J. Stephen Jones and John C. Rewcastle1 Glickman Urological Institute, Cleveland Clinic Foundation, Cleveland, OH, USA 1Department of Radiology, University of Calgary, Calgary, AB, Canada For correspondence: Dr. J. Stephen Jones, Glickman Urological Institute, Cleveland Clinic Foundation, A-100, 9500 Euclid Ave., Cleveland, OH 44195, USA. E-mail: joness7@ccf.org This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Other Sections▼ Abstract INTRODUCTION MATERIALS AND METHODS RESULTS DISCUSSION CONCLUSION REFERENCESAbstract Introduction and Objective: The increased use of cryoablation as an initial treatment for localized high-grade prostate cancer has been due to many factors including reports that cell kill from exposure to cryogenic temperatures is independent of cellular dedifferentiation and Gleason score. The objective of this study is to report the outcomes of primary cryoablation when used to treat Gleason 8, 9, or 10 localized prostate cancer at a large number of centers. Materials and Methods: Data from 1608 patients who underwent primary cryoablation at 27 centers were collected using the Cryo OnLine Database (COLD) registry. This analysis considers only the 77 patients who had a Gleason score of at least 8 and a minimum of 24 months of follow-up. Biochemical failure was defined according to both the original ASTRO definition (three rises) and the 2006 updated ASTRO (Phoenix) definition of nadir + 2. Biopsy was performed at the physician’s discretion, but most commonly if a patient had a rising or suspicious prostate specific antigen (PSA). Results: The average age at treatment was 69.6 ± 8.2 years. Pretreatment PSA was 16.2 ± 17.9 ng/ml and the average Gleason was 8.5 ± 0.6. Patients were followed for 39.0 ± 18.8 months (range: 24-120 months) and 5-year follow-up was available for 12 patients. Eight-seven percent of the patients achieved a PSA nadir < 0.4 ng/ml. Five-year actuarial biochemical survivals was 64.4 ± 6.0% and 44.6 ± 8.0% for the ASTRO and Phoenix definitions, respectively. A total of 47 underwent posttreatment biopsy. Of these, 12 showed evidence of disease resulting in a positive biopsy rate for those who underwent biopsy of 25.5%. This yields a positive biopsy rate of the entire population of 15.6% (12/77). Conclusions: Cryoablation, as a primary treatment for high-grade Gleason prostate cancer practiced over a wide spectrum of users provides definable biochemical and local control for a hard to manage patient population with aggressive disease. Keywords: Cryotherapy, prostate cancer, minimally invasive Other Sections▼ Abstract INTRODUCTION MATERIALS AND METHODS RESULTS DISCUSSION CONCLUSION REFERENCESINTRODUCTION Despite the well-recognized stage migration that has led to an improvement in prostate cancer outcomes since the era of prostate specific antigen (PSA)-based prostate cancer screening began, patients with high-grade prostate cancer remain at significant risk of morbidity and mortality.[1] Patients with Gleason score >8 cancer are often treated with radical prostatectomy or radiotherapy combined with adjuvant androgen blockade. Some patients have confounding factors limiting their ability to undergo surgery, including age, anesthetic risks, or simply refusal of surgical intervention. External beam radiotherapy in combination with 6-24 months’ hormonal ablation offers a nonsurgical alternative, and brachytherapy or the combination of external beam radiotherapy with brachytherapy is used for some high-risk patients as well. These options carry substantial risk of complications, including erectile dysfunction, incontinence, or damage to the surrounding structures that continue to limit their acceptance for some patients. Moreover, the efficacy of any modality decreases in patients with high-grade disease.[1]Cryosurgical ablation has been used in many centers as a minimally invasive alternative to surgery and radiation that has the potential to eradicate prostate cancer irrespective of tumor grade. Unlike radiotherapy, cryoablation appears to reproducibly kill all cells frozen to lethal temperatures.[2] This has led to the suggestion that it may be preferentially useful for patients with high-grade disease.[3]This study reports a relatively large group of patients diagnosed with Gleason 8, 9, or 10 prostate cancer who underwent cryoablation as their primary therapy. Patient data were collected with the Cryo OnLine Database (COLD) registry. Other Sections▼ Abstract INTRODUCTION MATERIALS AND METHODS RESULTS DISCUSSION CONCLUSION REFERENCESMATERIALS AND METHODS The COLD registry is a secure web-based registry consisting of case report forms designed to collect relevant pre- and post-treatment information for patients undergoing prostate cryoablation. A central institutional review board’s approval covers the collection and analysis of deidentified data, additional IRB approval for individual centers has been obtained when required by institutional policy. Investigators who have entered data into the COLD registry are listed in the acknowledgments.Only patients with Gleason score 8 or greater having minimum 24 months follow-up were included in this analysis. Patients undergoing cryotherapy following failure of prior definitive radiotherapy or brachytherapy, and those that had undergone focal, nerve sparing, or nerve warming treatment were excluded. A total of 77 patients from 27 centers were identified meeting the criteria.Biochemical failure was defined according to both the original ASTRO definition of three consecutive rises following nadir (referred to as “ASTRO”), and the second ASTRO definition of nadir + 2 (referred to as the “Phoenix” definition). Biopsy was performed at the physician’s discretion, but most commonly if a patient had a rising or suspicious PSA.Kaplan-Meier analysis was used to generate curves showing the probability biochemical failure as a function of time. Statistical analysis was performed with a commercially available statistical software package (MedCalc, Mariakerke, Belgium). Other Sections▼ Abstract INTRODUCTION MATERIALS AND METHODS RESULTS DISCUSSION CONCLUSION REFERENCESRESULTS Data were collected from 27 investigators. The average age of the 77 patients who met the inclusions criteria was 69.6 ± 8.2 years. Pretreatment PSA was 16.2 ± 17.9 ng/ml and the average Gleason was 8.5 ± 0.6. Patients were followed for 39.0 ± 18.8 months (range: 24-120 months) and 12 patients had a follow-up of at least 60 months. Posttreatment, 87% of the patients achieved a PSA nadir < 0.4 ng/ml. The 5-year actuarial biochemical survivals are 64.4 ± 6.0% and 44.6 ± 8.0% for the ASTRO and Phoenix definitions, respectively [Figure 1]. After treatment, 47 underwent biopsy. Of these, 12 showed evidence of disease. The positive biopsy rate, for those who underwent posttreatment biopsy was 25.5% and the rate for the entire population was 15.6% (12/77). No fistulas were identified in any of the patients. Figure 1 Kaplan-Meier curve of the cumulative biochemical disease free survival probability using (a) the ASTRO definition and (b) the Phoenix definition Other Sections▼ Abstract INTRODUCTION MATERIALS AND METHODS RESULTS DISCUSSION CONCLUSION REFERENCESDISCUSSION The COLD registry project is designed to address the relative paucity of published data regarding cryotherapy for prostate cancer. It is notable, however, that opinions regarding the quality and quantity of data published on radical prostatectomy, external beam radiation, and active surveillance are perhaps overstated. For example, the Kaplan-Meier 5-year biochemical disease free survival data for high-risk prostate cancer managed with external beam radiotherapy as shown in Campbell’s Urology textbook is based upon a surprisingly low six patients with at least 60 months follow-up. Similarly, the present series reports only 12 patients with results at 5 years. We believe that both datasets are inadequate to make solid declarations of long-term efficacy. That being said, the authors do feel it is important to realize that the data supporting any form of treatment for the high-risk patient is lacking[1] and that the concept that radiation therapy is clearly established as a more efficacious treatment for high-risk disease must be scrutinized.Emerging technologies are often reserved in initial series to low-risk patients in whom failure to control disease carries less risk of metastasis and death. For example, most initial brachytherapy series are heavily weighted toward patients with low-risk disease.[4] Moreover, even recent radical prostatectomy and radiation series include more low risk than high-risk patients, but this is at least partially due to high-risk disease being less common in screened populations.[5,6] In contrast, early pioneers of cryotherapy advocated the position that if lethal cold temperatures are achieved, uniform necrosis results and cell death occurs irrespective of cellular differentiation or Gleason score.[2] In addition, publications suggesting its potential to treat locally advanced disease has led to the concept of freezing beyond the prostatic capsule to eliminate extraprostatic disease that would have resulted in a positive surgical margin had radical prostatectomy been performed.[7] As a result, cryoablation is often utilized for the treatment of high-risk localized prostate cancer. Several publications of intermediate-term results have suggested that the efficacy of the procedure appears to be equivalent to radiation and surgery for low-risk prostate cancer and potentially more efficacious for moderate- and high-risk prostate cancer.[8–11] A summary of the efficacies reported in the four publications reporting 5 year outcomes exclusively for primary cryoablation is presented in Table 1. Table 1 Biochemical disease free survival at 5 years following cryoablation: Reports in the literature As of yet there is no universally agreed upon definition of biochemical failure following cryotherapy, but it should be noted that consensus definitions also remain relatively elusive following radiation or surgery. Radical prostatectomy completely removes the prostate and should theoretically yield an undetectable PSA. However, some residual PSA remains detectable in many patients due to a small number of remaining benign glands. The American Urological Association (AUA) Guidelines Panel recommended in 2007 that the definition of biochemical success does not require an undetectable PSA, and that failure should be a PSA > 0.2 ng/ml confirmed by a second PSA reading > 0.2.[12] Further, the AUA panel found 166 different published definitions of biochemical failure, including 99 for patients undergoing radiation failure. In 1998 the first ASTRO definition of three consecutive rises, backdated to the midpoint of the first rise, was agreed upon by a consensus panel and became standard practice. It is the ASTRO definition that has been used most commonly following cryoablation. This is based on the similarity of cryoablation and radiation therapy in that both modalities result in some residual prostatic tissue and low but measurable PSA levels in most patients. The second ASTRO definition, dubbed the “Phoenix” definition, remains somewhat controversial in the eyes of many urologists. Although it was specified that it was not intended for use with patients undergoing cryotherapy, we have included our results using this as an additional definition solely for comparative purposes.[13]Early cryotherapy experience made it clear that specific thresholds may be meaningless due to PSA production by residual tissue surrounding the urethra or in a benign median lobe, and the fact that a PSA of 0.4 is expected when 1 g of prostate tissue has been preserved in men free of prostate cancer.[14] It is intended that the data set collected with the COLD registry will be used to create a scientifically based definition of biochemical failure that is specific to primary prostate cancer cryoablation as these data accumulate and mature.The use of negative biopsies as a surrogate for disease control is also controversial. Regardless of the intervention, sampling error underestimates disease when using biopsy as a surrogate. This is especially likely when small volume disease is present, as evidenced by the 61% of men known to have prostate cancer that have a negative repeat sextant biopsy when evaluated on an active surveillance protocol.[15] Seventeen percent of patients with known prostate cancer on an active surveillance protocol have a negative biopsy even when saturation biopsy is performed.[16] Some authors suggest that histological evidence of malignancy identified on biopsy should not be regarded as cancer in some postradiation settings.[17] In contrast, following cryoablation, histological results tend to fall into one of three definitive categories: fibrous tissue (scar) indicating tumor eradication, benign prostate tissue, or prostate cancer.[18] When cryotherapy was first investigated most patients underwent posttreatment biopsy to confirm local control. However, due to high-negative biopsy rates (82-98%)[8,9] most practitioners now utilize biopsy only to investigate suspicious PSA values or patterns.[19] It is not possible to know what the positive biopsy rate would be for those not determined to warrant biopsy by the treating physicians, but previous series have suggested that the likelihood of residual disease is low as demonstrated in the table.The primary limitation of this series is the retrospective nature of a registry. There is the potential that patients with unfavorable features are not voluntarily reported to the registry, or that unfavorable outcomes are inaccurately reported. Our experience in dealing directly with the physician members and with internal audit is that we have found no evidence that there is any case selection, and to our knowledge all cases of the enrolling physicians are included. In addition, a wide variety of surgical techniques is possible with the large number of institutions participating. However, a primary goal of the COLD registry is to determine outcomes in “the real world” without the inherent reporting bias of single surgeon series. These data suggest that bDFS and complication rates are consistent with earlier single-center reports. CONCLUSION The biochemical and local control of cryoablation for high Gleason score prostate cancer appear to be consistent both with early reports of cryoablation and with large series reporting experience with radiation and surgery. Improving data available on all treatment modalities for localized prostate cancer is mandatory for patients to make an informed decision on therapy. Acknowledgments This analysis is based on data entered into the COLD registry. The contributing investigators include: AN Avallone, Grand Rapids, MI; DK Bahn, Ventura, CA; BT Brown, Daytona Beach, FL; A Cantwell, Daytona Beach, FL; DO Chinn, Arcadia, CA; M Chinn, Arcadia, CA; R Chopra, Port Orange, FL; FC Derrick, Charleston, SC; M Dineen, Daytona Beach, FL; HB Epstein, St. Augustine, FL; J Foley, Easton, MD; RW Given, Norfolk, VA; M Grable, Orange City, FL; RF Graves, Scottsbluff, NE; JM Greenberg, Tucson, AZ; R Kahnoski, Grand Rapids, MI; AE Katz, New York, NY; DL Laub, Santa Barbara, CA; MA Melser, Port Charlotte, FL; M Merrell, Daytona Beach, FL; KR Orton, Tucson, AZ; TH Patterson, Galesburg, IL; R Regan, Daytona Beach, FL; GS Rosenberg, Hackensack, NJ; SM Scionti, Hilton Head Island, SC; J Wescott, Daytona Beach, FL; AR Wirtshafter, Miami Beach, FL. Footnotes Source of Support: The COLD registry is supported through an educational grant from Endocare, Inc. Conflict of Interest: None declared. Other Sections▼ Abstract INTRODUCTION MATERIALS AND METHODS RESULTS DISCUSSION CONCLUSION REFERENCESREFERENCES 1. Fletcher SG, Theodorescu D. Surgery or radiation: what is the optimal management for locally advanced prostate cancer? Can J Urol. 2005;1:58–61. [PubMed] 2. Larson TR, Rrobertson DW, Corica A, Bostwick DG. In vivo interstitial temperature mapping of the human prostate during cryosurgery with correlation to histopathologic outcomes. Urology. 2000;55:547–52. [PubMed] 3. Bahn DK, Silverman P, Lee F, Sr, Badalament R, Bahn ED, Rewcastle JC. In treating localized prostate cancer the efficacy of cryoablation is independent of DNA ploidy type. Technol Cancer Res Treat. 2004;3:253–7. [PubMed] 4. Ragde H, Blasko JC, Grimm PD, Kenny GM, Sylvester JE, Hoak DC, Landin K, Cavanagh W. Interstitial iodine-125 radiation without adjuvant therapy in the treatment of clinically localized prostate carcinoma. Cancer. 1997;80:442–53. [PubMed] 5. Walsh PC. Comparison of the efficacy of local therapies for localized prostate cancer in the prostate-specific antigen era: A large single-institution experience with radical prostatectomy and external-beam radiation. J Urol. 2003;169:1593, 1594. 6. D’Amico AV, Hui-Chen M, Renshaw AA, Sussman B, Roehl KA, Catalona WJ. Identifying men diagnosed with clinically localized prostate cancer who are at high risk for death from prostate cancer. J Urol. 2006;176:S11–5. [PubMed] 7. Jones JS. Ultrasound probe positioning to minimize the risk of rectourethral fistula during cryosurgical ablation of prostate cancer. BJU Int. 2007 Apr 8; 8. Long JP, Bahn D, Lee F, Shinohara K, Chinn DO, Macaluso JN., Jr Five-year retrospective, multi-institutional pooled analysis of cancer-related outcomes after cryosurgical ablation of the prostate. Urology. 2001;57:518–23. [PubMed] 9. Donnelly BJ, Saliken JC, Ernst DS, Ali-Ridha N, Brasher PM, Robinson JW, Rewcastle JC. Prospective trial of cryosurgical ablation of the prostate: five-year results. Urology. 2002;60:645–9. [PubMed] 10. Bahn DK, Lee F, Badalament R, Kumar A, Greski J, Chernick M. Targeted cryoablation of the prostate: 7-year outcomes in the primary treatment of prostate cancer. Urology. 2002;60:3–11. [PubMed] 11. Prepelica KL, Okeke Z, Murphy A, Katz AE. Cryosurgical ablation of the prostate: high risk patient outcomes. Cancer. 2005;103:1625–30. [PubMed] 12. Cookson MS, Aus G, Burnett AL, Canby-Hagino ED, D’Amico AV, Dmochowski RR, Eton DT, Forman JD, Goldenberg SL, Hernandez J, Higano CS, Kraus SR, Moul JW, Tangen C, Thrasher JB, Thompson I. Variation in the definition of biochemical recurrence in patients treated for localized prostate cancer: The American Urological Association Prostate Guidelines for Localized Prostate Cancer Update Panel report and recommendations for a standard in the reporting of surgical outcomes. J Urol. 2007;177:540–5. [PubMed] 13. Roach M, Hanks G, Thames H, Jr, Schellhammer P, Shipley WU, Sokol GH, Sandler H. Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: recommendations of the RTOG-ASTRO Phoenix Consensus Conference. Int J Radiat Oncol Biol Phys. (3rd) 2006;65:965–74. [PubMed] 14. Akdas A, Cevik I, Tarcan T, Turkeri L, Dalaman G, Emerk K. The role of free prostate-specific antigen in the diagnosis of prostate cancer. Br J Urol. 1997;79:920–3. [PubMed] 15. Patel MI, DeConcini DT, Lopez-Corona E, Ohori M, Wheeler T, Scardino PT. An analysis of men with clinically localized prostate cancer who deferred definitive therapy. J Urol. 2004;171:1520–4. [PubMed] 16. Abouassaly R, Lane BR, Jones JS. Staging saturation biopsy in patients with prostate cancer on active surveillance protocol. Urology. 2008;71:573–7. [PubMed] 17. Petraki CD, Sfikas CP. Histopathological changes induced by therapies in the benign prostate and prostate adenocarcinoma. Histol Histopathol. 2007;22:107–18. [PubMed] 18. Donnelly BJ, Saliken JC, Ali-Ridha N, Rewcastle JC, White LJ. Histological findings in the prostate two years following cryosurgical ablation. Can J Urol. 2001;8:1237–9. [PubMed] 19. Ellis DS, Manny TB, Jr, Rewcastle JC. Cryoablation as primary treatment for localized prostate cancer followed by penile rehabilitation. Urology. 2007;69:306–10. [PubMed]

Saw palmetto no better than placebo for prostate problems

“I get many questions from patients about saw palmetto and its efficacy for the treatment of BPH or enlarged prostate.  Here is an interesting article discussing a head to head trial of saw palmetto versus placebo for symptoms of enlarged prostate.”  D.R.

Saw palmetto no better than placebo for prostate problems

By Anne Harding, Health.com updated 6:34 PM EST, Tue September 27, 2011

In clinical trials, saw palmetto has consistently failed to outperform placebo. STORY HIGHLIGHTS Clinical trial finds herbal extract no better than sugar pills for enlarged prostate Saw palmetto has long been marketed as a remedy for symptoms Doctor: “I wouldn’t object, given the no side effects, if men wanted to try it” (Health.com) — The millions of middle-aged men who take saw-palmetto supplements to cope with the symptoms of an enlarged prostate might as well be popping sugar pills. That’s the conclusion of a new clinical trial, published this week in the Journal of the American Medical Association, that found that the herbal extract is no better than placebo at reducing bathroom trips or otherwise improving the urinary-tract symptoms associated with prostate enlargement. “There’s probably no real benefit,” says Simon J. Hall, M.D., the chairman of the urology department at the Mount Sinai School of Medicine, in New York City, who wasn’t involved in the new research. “Ultimately, the way I would look at it is: Is it worth spending $20 or $30 a month to take something that is probably not going to do anything?” Health.com: Must-know facts about male incontinence Nearly all men experience some prostate-gland growth as they age. Most have no obvious symptoms, but because the prostate surrounds the urethra, this otherwise harmless enlargement (known as benign prostatic hyperplasia) sometimes causes symptoms such as dribbling after urination, a weak urine stream, and the frequent need to wake up at night to urinate. Saw palmetto has long been marketed as a remedy for these symptoms, but in clinical trials it has consistently failed to outperform placebo. A 2009 review of 30 randomized controlled trials — including a rigorous 2006 study published in the New England Journal of Medicine — concluded that the herbal extract was no more effective than placebo. In the new study, the largest of its kind to date, the researchers randomly assigned 369 U.S. and Canadian men with prostate-related symptoms to take saw-palmetto capsules or an identical placebo. After 18 months, the men taking saw palmetto were doing no better than those on placebo, even though the dosage of saw palmetto was increased twice during the study, to 960 milligrams — three times the typical daily dose. Health.com: Bladder training tips to reduce bathroom trips Neither saw palmetto nor placebo made a substantial dent in the men’s symptoms. At the beginning of the study, the average severity of the men’s symptoms measured about 14.5 on a 35-point scale commonly used by urologists; by the end, the average severity had declined by three points in the placebo group and just two points in the saw palmetto group. Lead author Michael J. Barry, M.D., a primary care physician at Massachusetts General Hospital, in Boston, points out that between 40% and 45% of the men in both groups saw a “perceptible improvement” in their symptoms, however. That improvement can be chalked up only to the placebo effect, not to any active ingredients in the saw-palmetto extract. But that doesn’t necessarily mean that men shouldn’t take saw palmetto, Barry says. “We can’t show, on the one hand, that it’s better than placebo, but some men do have an improvement in their symptoms, and there seem to be virtually no side effects,” he says. “I wouldn’t object, given the no side effects, if men wanted to try it.” Health.com: 12 myths and facts about incontinence Hall says he doesn’t discourage his patients from taking saw palmetto if the placebo effect appears to be working. “Certainly I’ve had patients tell me…’I’m taking saw palmetto and it’s great,’ and I tell them to keep taking it,” he says. Saw palmetto, with just under $19 million in sales, was the second bestselling herbal supplement in the United States in 2010 (behind cranberry), according to the SymphonyIRI Group, a Chicago-based market-research firm. Barry and his colleagues used a proprietary brand of saw palmetto manufactured in Germany. Since other studies using different brands have had similarly disappointing results, it’s unlikely that one brand is more effective than another, he says. Health.com: Natural remedies for incontinence The study was funded and partially overseen by the National Institutes of Health, although the supplement manufacturer provided all of the saw palmetto and placebo capsules. Other treatment options for prostate-enlargement symptoms include prescription drugs and surgery. In most cases, Hall says, treatment is actually not necessary unless there’s a true medical problem — if a man is not able to completely empty his bladder, for example, or if he experiences recurrent bladder infections. Copyright Health Magazine 2011

New PSA Screeing Recommendations May Cost Patient His Life

Dr. Deepak A. Kapoor is president of Advanced Urology Centers of New York and president of the Large Urology Group Practice Association.

Recently one of our patients made a decision that may well cost him his life. John Smith (not his real name) is a 51-year-old who had an elevated prostate specific antigen (PSA) during a routine prostate cancer screening exam. After a blood test confirmed our concerns, he had a biopsy — and, though he had no other symptoms, the patient was found to have multiple areas of high-grade prostate cancer. After obtaining several opinions, he scheduled minimally invasive robotic surgery to have his prostate removed.
But then, the United States Preventive Service Task Force issued recommendations that PSA screening is unnecessary, saying that asymptomatic men whose cancer is detected via screening are unlikely to die from their disease. Based on this, Smith canceled his surgery. And despite our attempts to explain that ongoing observation is not appropriate for his aggressive disease, he is adamant in his refusal to have treatment.
The true tragedy is that the task force, which is chaired by a pediatrician and includes no specialists who treat prostate cancer, made this recommendation based on controversial and contradictory studies and inexplicably ignored data on prostate cancer incidence and mortality.
In 2009, this same group suggested mammograms were unnecessary for women younger than 50, and recommended against teaching women to do breast self-exams. Due to public outrage, these recommendations were almost immediately retracted. To avoid further embarrassment at that time, the panel decided not to fully release its prostate cancer screening recommendations, and then just issued a limited opinion suggesting PSA screening was not warranted for patients older than 75. Since then, only one additional screening study has been published, which demonstrated a 44 percent decrease in prostate cancer death rates among Swedish men who received screening compared with those who did not.
Without question, prostate cancer can be a slow-growing disease for some men. But it is fatal for many others, with the National Cancer Institute predicting nearly 34,000 prostate cancer deaths this year. It is the second-leading cause of cancer deaths for American men, after lung cancer.
But we have made enormous strides in treating this disease. Before PSA screening, the 10- year survival for prostate cancer was 53 percent; it’s now over 97 percent. Since the advent of widespread PSA screening in the early to mid 1990s, the death rate from prostate cancer has decreased by nearly 40 percent, while during that interval the incidence of prostate cancer is virtually unchanged. We are diagnosing prostate cancer earlier, and saving lives.
The task force suggests that no one without symptoms be screened, but every urologist knows this is a grave mistake. By the time prostate cancer is symptomatic, the opportunity for cure is lost. Screening, though not perfect, provides patients with information that they can use to make the best decisions for themselves. To suggest that no man have this information because of concerns regarding treatment that they may never receive is a scientific bait-and-switch of the worst order.
Shortly after release of the task force recommendations, President Barack Obama, after discussion with his doctor, chose to have PSA screening. These recommendations open the door for government and third-party payers to stop covering this test, meaning that the average man may be unable to make that same choice. And men like Mr. Smith who don’t show symptoms might never be able to make an informed decision about treatment until it is too late. Every patient should be able to do just what the president did — make a screening decision with his own doctor, and not have that choice made for him by insurance executives or government bureaucrats.
Massive public outcry saved breast cancer screening for women, and studies show that screening efficiency for prostate cancer is similar to that for breast cancer. Those of us concerned with men’s health must make our voices heard to prevent these premature and ill-advised recommendations from ever being enforced. That will help save the lives of thousands of Mr. Smiths nationwide.