AUA look-back: TRT safety, PCa tests spark news, debate

May 29, 2014

The recently concluded AUA annual meeting in Orlando may not go down as one of the most memorable annual meetings in recent years. Nevertheless, it was noteworthy for some interesting news and lively debate on hot-button topics: the safety of certain urologic products, namely, testosterone and transvaginal mesh; new tests for prostate cancer; infection prevention and treatment; and use of an advanced prostate cancer agent in the pre-chemotherapy setting.

The recently concluded AUA annual meeting in Orlando may not go down as one of the most memorable annual meetings in recent years. Nevertheless, it was noteworthy for some interesting news and lively debate on hot-button topics: the safety of certain urologic products, namely, testosterone and transvaginal mesh; new tests for prostate cancer; infection prevention and treatment; and use of an advanced prostate cancer agent in the pre-chemotherapy setting.

Unlike the meeting’s last three installments, where the focus was squarely on prostate cancer screening and associated guidelines, this event lacked a singular theme or focus. In the words of one urologist I spoke with, the Orlando meeting had little “buzz.” Attendance seemed light, although official attendance figures were not available as of this writing.

This was my 18th annual meeting as Urology Times’ chief editor. Here are a few of the trends that caught my attention from the scientific sessions, visits with attendees, and social media. This is not meant to be a comprehensive report; for that, watch for our annual “Best of AUA” article on the meeting’s take-home messages, coming soon.

Safety of testosterone, mesh

Key stakeholders debated the use of testosterone replacement therapy in men with hypogonadism, which has come under attack since the publication of two studies suggesting an increased risk of cardiovascular events associated with TRT. William Finkle, PhD, an author of one of the studies (PLoS One 2014; 9:e85805), and Adriane Fugh-Berman, MD, a pharmacologist whose research examines pharmaceutical marketing, discussed the evidence of increased cardiovascular risk following TRT. Abraham Morgentaler, MD, took the studies and researchers to task.

“Morgentaler systematically deconstructed (ie tore to shreds) Finkle and Fugh-Berman's argument. Great lecture on basic stats, ethics,” Christopher Bayne, MD, tweeted during the meeting.

Morgentaler systematically deconstructed (ie tore to shreds) Finkle and Fugh-Berman's argument. Great lecture on basic stats, ethics #AUA14

- Christopher Bayne (@CBayneMD) May 19, 2014

Not all urologists disagree that TRT is overused. “Is testosterone being abused? Yes. All over the world,” said Ajay Nangia, MD. “This is giving us all a bad name.”

"Is testosterone being abused? Yes. All over the world...This is giving us all a bad name" - Dr. Nangia #AUA14

- Amer. Urol. Assn. (@AmerUrological) May 16, 2014

Like TRT, the safety of transvaginal mesh has also drawn interest from the FDA, not to mention eager trial lawyers. A Cleveland Clinic study found that 61% of women presenting to their center with pelvic organ prolapse or stress incontinence were aware of the FDA safety communication concerning mesh. But two-thirds were unsure if the mesh used for SUI was different from that used for POP, and half incorrectly believed mesh had been recalled. Urologists can play an important role in clarifying these misconceptions.

Continue to next page for more.

 

New prostate cancer tests

Researchers presented validation studies on a growing number of biomarker-based prostate cancer tests, including those designed to determine tumor aggressiveness and those aimed at determining the risk for repeat biopsy.

Three separate studies of the gene-based Prolaris test showed that: for each one-unit increase in Prolaris score, patients being managed conservatively had double the risk of dying from prostate cancer; the test performed significantly better than Gleason upgrading in predicting which men would experience biochemical recurrence after radical prostatectomy; and the test was a stronger predictor of metastatic disease than any other tested clinical variables in men who had undergone prostatectomy.

Study results on the ConfirmMDx, an epigenetic assay, validated the test as the most significant predictor of risk for the presence of occult cancer compared with other risk factors used to guide the decision for repeat biopsy.

The 4Kscore test, which measures the levels of four kallikrein proteins in the prostate, was shown to discriminate between men with high-grade, aggressive prostate cancer and those with no findings of cancer or low-grade disease. The test could potentially reduce prostate biopsies by 30% to 50%.

The newest test on the block is the Prostate Health Index(phi), which became available commercially last month. Three times more specific in detecting prostate cancer than PSA, phi was shown in a recent multicenter clinical to reduce unnecessary biopsies due to false-positive results by 31%.

Finally, specialized bomb-sniffing dogs showed an uncanny ability to detect prostate cancer in urine samples. If there was a “media darling” award from this year’s meeting, this study would have grabbed it.

Infection

Strong, clinically relevant research on infection was prominent this year not only in the Infection/Inflammation poster sessions, but also in the Epidemiologic Trends/Socioeconomic and Pediatrics sessions. Infection-more specifically, antibiotic resistance in both adults and children-is more than a urologic problem; it is a major public health concern.

At this meeting, much of the focus continues to be on minimizing infectious complications after prostate biopsy. I like this quote from Michael Liss, MD, who presented findings from a large study on post-biopsy infection risk based on fluoroquinolone-resistant colonization status: “Our results support performing pre-biopsy rectal swab culture in all men undergoing prostate biopsy in which fluoroquinolone prophylaxis is planned.”

Continue to next page for more.

 

Pre-chemo use of androgen inhibitor

A growing body of evidence continues to build for the use of enzalutamide (XTANDI) in men with chemotherapy-naïve metastatic castrate-resistant prostate cancer. At this meeting, data from the PREVAIL study showed for the first time that the drug’s benefits extend to men with both visceral and nonvisceral metastases.

Interestingly, while nearly half of the PREVAIL investigators around the world were urologists, urologists accounted for only 2% of the investigators in the U.S. “The outcomes data speak to the potential for urologists to manage chemotherapy-naïve mCRPC patients, but the information about the investigators show that in the U.S., urologists are not embracing this role,” said PREVAIL investigator Christopher Evans, MD.

The FDA is expected to rule on whether to approve enzalutamide for a pre-chemo indication on Sept. 18.

Active surveillance

Active surveillance for men with low-risk prostate cancer was a good news-bad news story.

A University of Toronto study of men with favorable-risk disease found that their likelihood of dying of other causes was 9.7 times greater than the likelihood of dying from prostate cancer, and they concluded that active surveillance for these men is feasible and appears safe 15 to 20 years after diagnosis. In contrast, Swiss researchers reported that more than one-fourth of men on surveillance failed to show up for recommended appointments, and Swedish researchers reported that delayed radical prostatectomy was associated with a greater risk of an increased Gleason score at time of surgery.

Another study reported on a new nomogram may help predict the risk of disease progression in men on surveillance.

Continue to next page for more.

 

New AUA guidelines, updates

The AUA released several new clinical guidelines. They cover medical management of kidney stones, evaluation and treatment of cryptorchidism, and urologic trauma. In addition, updates were made to existing guidelines, including those on castration-resistant prostate cancer (discussion of radium-223 added) and overactive bladder (statements added on beta-3 adrenoceptor agonists, onabotulinumtoxinA, peripheral tibial nerve stimulation, and sacral neuromodulation).

All AUA guidelines are available online. I was surprised to hear that many urologists do not read them. Guidelines are meant to be an important benefit to urologists and their patients, not an intrusion into your practice.

Public health and public discourse

Other notable news and observations from this year’s meeting:

• Studies raised awareness of public health issues, including one showing that use of seat belts and airbags reduces renal injury among individuals involved in motor vehicle crashes. 

• The fiery debate format of the new “crossfire” sessions drew strong attendance and rave reviews from attendees. One memorable quote came from William Catalona, MD, in a crossfire debate with Ballentine Carter, MD, and others: “If Dr. Carter doesn’t think PSA has reduced metastatic disease, I wonder what planet he’s been on for the past 20 years."

Thanks @AmerUrological for a fantastic #AUA14 Crossfires session- enjoyed watching the feisty debate between my mentors Catalona & Carter!

- Stacy Loeb, MD (@LoebStacy) May 16, 2014

Congratulations to @AmerUrological for this brilliant crossfire debate session. The auditorium is packed! #AUA14pic.twitter.com/iAbSr9ZjZz

- Henry Woo (@DrHWoo) May 16, 2014

• Social media’s impact on medicine cannot be underestimated, and the AUA recognized this by setting up a social media lounge, where the “urotwitterati” helped urologists get acquainted with social media. Nearly 8,000 tweets using the #aua14 hashtag were served up, and among urologists, Stacy Loeb, MD, earned the most mentions at 465.

A fantastic effort all urotwitterati-safe to say all #SoMe records rewritten #AUA14http://t.co/nQS5PZh8Ocpic.twitter.com/AdL5Cxv0SR

- Rustom Manecksha (@Dr_RPM) May 20, 2014

• Several urologists, especially those in academia, took to Twitter to express their sadness over the passing of John Fitzpatrick, MCh. They left little doubt how highly regarded Dr. Fitzpatrick was as a urologic researcher, clinician, and friend.

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