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With the AUA annual meeting quickly approaching, Victor W. Nitti, MD, chair of the AUA Office of Education, provides a snapshot of new course offerings and other AUA educational opportunities.

Dr. Nitti: 32 new courses on tap at AUA 2019

“As many other practices have found, [advanced practice providers] help us to improve access, increase capacity, keep our costs low, and just as important, they allow our urologists to focus on more complex functions,” writes Barry A. Kogan, MD.

APPs are not just for your iPhone

"The nurse practitioner that I work with is not only very knowledgeable in office-based pediatric urology but also, for problems like voiding dysfunction, more available to spend extra time with patients and their families," writes Barry A. Kogan, MD.

Working with APPs: Try it, you’ll like it

The FDA has accepted a Biologics License Application (BLA) seeking approval of nivolumab (Opdivo) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20), or subcutaneous nivolumab, for the treatment of patients with all previously approved solid tumor indications for nivolumab as a monotherapy, monotherapy maintenance following completion of combination therapy with nivolumab plus ipilimumab (Yervoy), or in combination with chemotherapy or cabozantinib (Cabometyx).

Nivolumab is currently approved under several indications, including in combination with ipilimumab for the first-line treatment of patients with intermediate- or poor-risk advanced renal cell carcinoma (RCC), in combination with cabozantinib for the first-line treatment of patients with advanced RCC, for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy, and in combination with cisplatin and gemcitabine for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma.

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024.

 According to a news release from Bristol Myers Squibb,

 approval of the formulation would make it the first and only subcutaneously administered PD-1 inhibitor.

“We believe subcutaneous nivolumab has the potential to make a significant difference in the lives of patients, which is reinforced by the FDA’s acceptance of our application,” said Gina Fusaro, PhD, vice president, global program lead, Bristol Myers Squibb, in the news release.

 “Opdivo is a foundational PD-1 inhibitor approved for many different types of cancer, and our continued investment in research that puts patients first remains a priority. If approved by the FDA, the subcutaneous administration of nivolumab would provide patients and their physicians with a new option that delivers the same well-known benefits as IV Opdivo but with the improved convenience of an injection administered in 3 to 5 minutes rather than a 30-to-60-minute infusion.”

The BLA submission is supported by findings from the phase 3 CheckMate-67T trial (NCT04810078), in which subcutaneous nivolumab met the study’s co-primary end points by demonstrating noninferiority to intravenous (IV) nivolumab regarding time average nivolumab serum concentration over 28 days (C

; geometric mean ratio [GMR}, 2.098; 90% CI, 2.001-2.200) and minimum serum concentration at a steady state (C

Data from the study, which were presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California,

 also showed that subcutaneous nivolumab demonstrated noninferiority to IV nivolumab in the key powered secondary end point of objective response rate (ORR). Specifically, the subcutaneous arm demonstrated an ORR of 24.2% (95% CI, 19.0-30.0) per blinded independent central review (BICR), compared with 18.2% (95% CI, 13.6-23.6) in the IV arm.

The safety profile for subcutaneous nivolumab was consistent with that of the IV formulation. Among patients who received the subcutaneous formulation, 8.1% experienced injection-site reactions, with all being low-grade and transient. Deaths due to study drug toxicity occurred in 3 patients in the subcutaneous arm and 1 patient in the IV arm. Most deaths that occurred during the study were due to disease progression.

In total, the phase 3, open-label CheckMate-67T trial enrolled 495 patients with advanced or metastatic ccRCC who had received prior systemic therapy. Patients were randomly assigned 1:1 to receive 1200 mg subcutaneous nivolumab plus rHuPH20 every 4 weeks (n = 248) or to 3 mg/kg IV nivolumab every 2 weeks (n = 247) for up to 2 years of treatment or until disease progression, unacceptable toxicity, withdrawal, or death.

The co-primary pharmacokinetic end points for noninferiority testing were C

 of subcutaneous nivolumab vs IV nivolumab. The key secondary end point was ORR per BICR.

Final completion of the CheckMate-67T study is expected in January 2026.

1. U.S. Food and Drug Administration accepts Bristol Myers Squibb’s application for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Bristol Myers Squibb. May 6, 2024. Accessed May 7, 2024. https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Application-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

2. Bristol Myers Squibb announces updated action date by the U.S. Food and Drug Administration for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Published online and accessed May 21, 2024. https://investors.bms.com/iframes/press-releases/press-release-details/2024/Bristol-Myers-Squibb-Announces-Updated-Action-Date-by-the-U.S.-Food-and-Drug-Administration-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

3. George S, Bourlon TB, Chacon MR, et al. Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T. 

4. A study of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread (CheckMate-67T). ClinicalTrials.gov. Last updated March 1, 2024. Accessed May 7, 2024. https://clinicaltrials.gov/study/NCT04810078

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024. 

News

FDA accepts BLA for subcutaneous nivolumab in solid tumors

Recent data presented at Pelvic Floor Disorders Week 2024 showed no significant association between the use of vaginal estrogen for the management of genitourinary syndrome of menopause (GSM) and subsequent major adverse cardiovascular events (MACE).

An additional study presented at the meeting showed no significant association between the use of systemic (non-vaginal) estrogen for vasomotor symptoms of menopause (VMS) and subsequent venous thromboembolic events (VTE).

According to the authors, vaginal estrogen therapies contain a listed contraindication for a history of myocardial infarction and stroke, as well as a black-box warning for increased risk of deep vein thrombosis. The current studies sought to assess the risk of these events in women who did and did not receive vaginal or systemic estrogen within 1 year following their diagnosis.

In total, the retrospective cohort analysis comparing vaginal estrogen and subsequent MACE included 549,925 women from the TriNetX database who received a diagnosis of GSM between April 2004 and April 2024. Among all patients, 53.8% received vaginal estrogen.

After propensity score matching, each study arm included 65,243 high-risk women (a diagnosis of MACE between 3 and 24 months prior to first GSM diagnosis) and241,326 low-risk women (no history of MACE). A subsequent MACE diagnosis included myocardial infarction, stroke, and cardiovascular death.

Among all high-risk women, a subsequent MACE diagnosis occurred in 23% of patients who received vaginal estrogen vs 23% of patients who were not treated with vaginal estrogen (HR, 0.990; 95% CI, 0.936 to 1.048; 

 = .423). In low-risk women, a subsequent MACE diagnosis occurred in 6.2% of patients who received vaginal estrogen vs 7.4% of patients who did not receive vaginal estrogen (HR, 0.938; 95% CI, 0.918 to 0.959; 

Similar results were seen when comparing the use of systemic estrogen for VMS and subsequent VTE.

In total, the retrospective study identified 526,144 women from the TriNetX database who received a diagnosis of VMS between April 2004 and April 2024. Among these patients, 7.4% received systemic estrogen. After propensity score matching, each study arm included564 high-risk women (a diagnosis of tobacco use by ICD-10 code any time prior to first VMS diagnosis) and 38,583 low-risk women (no history of prior tobacco use).

Among all high risk-women, subsequent VTE occurred in 2.0% of patients who received systemic estrogen compared with 2.8% of patients who did not receive systemic estrogen (HR, 0.774; 95% CI, 0.359 to 1.670; 

 = .750). Among low-risk women, subsequent VTE was experienced by 1.6% of patients who received systemic estrogen compared with 2.1% of patients who did not receive systemic estrogen (HR, 0.986; 95% CI, 0.887 to 1.097; 

“These findings support the safety of vaginal estrogen for treatment of local menopause symptoms, even in high-risk women,” concluded lead author Gabriella M. Rustia, MD, a female pelvic medicine and reconstructive surgery fellow at University Hospitals in Cleveland, Ohio, in correspondence with 

. “Further research should elucidate current practice patterns with systemic hormone replacement specific to route and dose of administration such as patch or oral routes.”

1. Rustia GM, Rahman A, Rhodes S, Sheyn D. Major adverse cardiovascular events with and without vaginal estrogen therapy. Presented at: Pelvic Floor Disorders Week 2024. October 22-25, 2024. Washington, DC

2. Rustia GM, Rhodes S, Sheyn D. Rate of venous thromboembolic events with and without systemic estrogen therapy. Presented at: Pelvic Floor Disorders Week 2024. October 22-25, 2024. Washington, DC

Recent studies presented at Pelvic Floor Disorders Week 2024 indicate no significant link between vaginal estrogen use for genitourinary syndrome of menopause (GSM) and major adverse cardiovascular events (MACE), nor between systemic estrogen for vasomotor symptoms (VMS) and venous thromboembolic events (VTE). The retrospective cohort analysis involved over half a million women from the TriNetX database. Results showed similar MACE and VTE rates in both high-risk and low-risk groups, regardless of estrogen therapy. These findings suggest the safety of estrogen therapies, even in high-risk populations.

“These findings support the safety of vaginal estrogen for treatment of local menopause symptoms, even in high-risk women,” says Gabriella M. Rustia, MD.

Vaginal estrogen for GSM not associated with major adverse cardiovascular events 

Two-year data from the pivotal OASIS trial (NCT03596671) demonstrate sustained efficacy of the Revi System, an implantable tibial neuromodulation system for patients with urgency urinary incontinence (UUI).

The findings were presented by Cindy L. Amundsen, MD, at Pelvic Floor Disorders Week 2024.

"These data show that the therapeutic benefits of the Revi System are not only sustained over time but also result in consistently high patient satisfaction and a favorable safety profile, representing a meaningful technological advancement in the treatment of urgency urinary incontinence,” said Amundsen, a urogynecologist at Duke University in Durham, North Carolina, in a news release on the findings.

Of the 151 patients initially enrolled in the trial, 97 completed the 24-month assessment. Of these, 79% experienced a response to therapy, and 56% achieved at least a 75% reduction in UUI episodes. The therapeutic response rate was 79%, which is comparable to the rates seen at 6 months (78%) and 12 months (82%).

Additionally, 97% of patients indicated that they were satisfied with the therapy, and 80% indicated that they felt “much better” or "very much better” at 2-year follow-up, per the Patient Global Impression of Improvement questionnaire.

Regarding safety, no serious device- or procedure-related adverse events were observed at 24 months. There was 1 delayed surgical site-related adverse event attributed to an “exuded non-absorbable, braided suture, resulting in a superficial infection,” which did not require explantation of the device.

The authors noted, “Subjects that completed both the 6-month assessment (n=144) and the 24-month assessment (n=97) had similar demographics and results at the 6-month visit, indicating that results at 24-months are representative of the overall study population.”

"These findings reinforce the durability of significant response and high patient satisfaction of the Revi system, highlighting its status as the leading solution for implantable tibial neuromodulation,” said Roger Dmochowski, MD, MMHC, FACS, chief medical officer of BlueWind Medical, in the news release.

 “As physicians increasingly become aware of Revi as an important UUI treatment option, we are excited to share these results with the global community of healthcare professionals dedicated to advancing care for incontinence."

In total, the prospective, multicenter, single-arm, open-label OASIS trial enrolled and implanted 151 female patients with UUI across clinical trial sites in the United States and Europe.

 Of those, 144, 140, and 97 patients completed the 6-, 12-, and 24-month visits, respectively. At baseline, patients demonstrated an average of 4.8 UUI episodes per day (SD, 2.9) and 10 voids per day (SD, 3.3). The average age of participants was 58.8 years (SD, 12.5).

Patients were eligible for enrollment if they experienced at least 9 UUI episodes on a 7-day diary. For the study, participants stimmed for approximately 30 minutes twice daily.

The primary efficacy end point was the proportion of responders to therapy, defined as at least a 50% improvement in the average number of UUI episodes at 6 months. The primary safety end point was the incidence of adverse events from implantation at 12 months following activation of the device. Secondary end points included the proportion of responders, defined as at least a 50% improvement in UUI episodes or severe UUI episodes at 12 months, and the severity of leaks.

the FDA granted a de novo marketing authorization

 to the Revi System based on initial 6- and 12-month data from the OASIS trial.

 showed that the study met its primary end point with 76.4% of patients in the intent-to-treat population demonstrating at least a 50% reduction in UUI episodes, which reached statistical significance in comparison with the predefined performance goal (

 < .0001). At 12-month follow-up, the clinical response rate was 78.4%.

In patients who completed 12-month diaries (n = 139), 82% achieved at least a 50% reduction in UUI episodes and 66.9% achieving at least a 75% reduction. Further, 37.8% and 50% of patients classified as dry on at least 3 consecutive diaries at 6- and 12-month follow-up, respectively.

Regarding safety, no procedure- or device-related serious adverse events (AEs) were reported. Additionally, no patients required surgical reintervention or revisions due to implant migration, lead breakage, or battery replacement. In total, 15 serious AEs and 285 AEs were reported.

1. Amundsen C, Heesakkers J, Toozs-Hobson P, et al. 2 year results: Revi therapy, implanted neuromodulator for urgency incontinence. Presented at: Pelvic Floor Disorders Week 2024. October 22-25, 2024. Washington, DC

2. Two-year Revi therapy data reinforce sustained efficacy and safety of implantable tibial neuromodulation in managing urgency urinary incontinence. BlueWind Medical, Ltd. October 24, 2024. Accessed October 25, 2024. https://www.businesswire.com/news/home/20241024044110/en/Two-Year-Revi%C2%AE-Therapy-Data-Reinforce-Sustained-Efficacy-and-Safety-of-Implantable-Tibial-NeuroModulation-in-Managing-Urgency-Urinary-Incontinence

3. Heesakkers JPFA, Toozs-Hobson P, Sutherland SE, et al. A prospective study to assess the effectiveness and safety of the BlueWind System in the treatment of patients diagnosed with urgency urinary incontinence. 

4. BlueWind Medical's Revi System secures U.S. FDA De Novo Classification grant for the treatment of urgency incontinence. News release. BlueWind Medical. August 17, 2023. Accessed October 25, 2024. https://www.prnewswire.com/news-releases/bluewind-medicals-revi-system-secures-us-fda-de-novo-classification-grant-for-the-treatment-of-urgency-incontinence-301903199.html?tc=eml_cleartime

The OASIS trial's 2-year data confirm the Revi System's sustained efficacy and safety for urgency urinary incontinence (UUI). The trial involved 151 patients, with 97 completing the 24-month assessment. Results showed a 79% therapeutic response rate, with 56% achieving a 75% reduction in UUI episodes. Patient satisfaction was high, with 97% satisfied and 80% feeling significantly improved. No serious adverse events were reported. The Revi System, which received FDA de novo marketing authorization, represents a significant advancement in implantable tibial neuromodulation for UUI treatment.

The therapeutic response rate was 79% at 24 months, which is comparable to the rates seen at 6 months (78%) and 12 months (82%). 

OASIS: Efficacy of Revi System for urgency incontinence maintained at 2 years

 found that certain racial and ethnic minority groups are misrepresented in urolithiasis clinical trials compared with the overall urolithiasis population in the United States.

For the study, the investigators assessed clinical trials indexed on PubMed from 2000 to 2022. Of the 180 urolithiasis clinical trials performed in the US during that time period, 40 (22%) reported race and ethnicity of participants and 104 (58%) trials reported sex of participants. Given that only 1 in 4 published trials reported race and ethnicity of participants, the authors note that improved reporting practices are needed to better reflect the diversity of the urolithiasis population.

Demographic data obtained from the included studies were then compared to the kidney stone prevalence reported by the National Health and Nutrition and Examination Survey from 2015 to 2018. A representation quotient was calculated to determine the concordance of representation on race/ethnicity and on sex, stratified by geographic location, study type, and funding source.

Overall, data from the study showed that both male and female participants were well represented in clinical trials, with representation quotients of 0.97 and 1.02, respectively.

Regarding race and ethnicity, data showed that Hispanic patients were consistently underrepresented in clinical trials, with a representation quotient of 0.46. Conversely, Black participants tended to be overrepresented, with a representation quotient of 1.84. The representation quotients for Asian American and Pacific Islander patients, White patients, and patient of mixed/other ethnicity was 1.06, 1.04, and 0.34, respectively.

When stratified by geographic location, the most proportional enrollment in clinical trials was seen among studies completed in the Western section and in multi-institutional trials. Trials completed in the South Central and Southeastern Sections tended to underrepresent Hispanic patients and those of mixed/other ethnicity.

Trial enrollment was similar when stratified by study type. When looking at funding source, trial that were industry funded tended to have more diverse enrollment compared with those that were academic-funded.

Co-author Amy M. Reed, MD, Capt, USAF, MF, an endourology and laproscopic surgery fellow at Vanderbilt University Medical Center in Nashville, Tennessee, explained in correspondence with 

®, “We feel our findings further urologic knowledge in 2 major ways. First, we found decreased enrollment of high-risk stone populations. By identifying enrollment trends within urolithiasis trials, we can work on understanding barriers to enrollment and how culture and socioeconomic factors may impact this community. Second, by using final published manuscripts, we highlight areas of improvement for communication of results by investigators and authors. Only 25% of urolithiasis trials publish these data and a significant number of those trials publish incomplete or reductive participant information. Understanding these limitations is important because clinical trial results inform the medical community to draw accurate conclusions and apply generalizable results to clinical practice.”

As such, the authors concluded, “Investigators should prioritize inclusive recruitment and improve reporting practices to accurately reflect the diversity of the urolithiasis population.”

1. Reed AM, Hsi RS. Diversity, equity, and inclusion in urolithiasis clinical trials: Representative enrollment by race, ethnicity, and sex. 

. 2024;11(4):685-691. doi:10.1097/UPJ.0000000000000595

A study in Urology Practice highlights the misrepresentation of racial and ethnic minorities in urolithiasis clinical trials in the US. Analyzing 180 trials from 2000 to 2022, only 22% reported race and ethnicity, and 58% reported sex. Hispanic patients were underrepresented, while Black participants were overrepresented. Geographic location and funding source influenced diversity, with industry-funded trials showing more diverse enrollment. The study emphasizes the need for inclusive recruitment and improved reporting to better reflect the urolithiasis population's diversity and ensure accurate, generalizable clinical trial results.

Data showed that Hispanic patients were consistently underrepresented in clinical trials, while Black participants tended to be overrepresented.

Study highlights need for improved enrollment, reporting in urolithiasis trials

The American Urological Association (AUA), the Society of Genitourinary Reconstructive Surgeons (GURS), and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) have released a joint amendment to the incontinence after prostate treatment guideline, the AUA announced in a news release.

The full guideline, which was first published in 2019, covers current diagnostic and treatment options for patients who experience incontinence after undergoing treatment for localized prostate cancer or benign prostatic hyperplasia (BPH).

“Urinary incontinence is a prevalent and highly impactful quality of life issue that can cause stress, depression, and social isolation if left untreated. We hope this amendment serves as a useful resource for clinicians who treat stress incontinence in men after prostate therapies such as prostatectomy, radiation, and benign prostatic hypertrophy surgery. We’ve provided guidance on the impact of radiation on urinary health as well as suggestions for counseling men about the risk factors for artificial urinary sphincter erosion, among other recommendations,” said guideline amendment chair Benjamin N. Breyer, MD, MAS, FACS, in the news release.

Breyer is also a professor and chair of urology at the University of California, San Francisco.

In total, the guideline includes 38 recommendations on managing incontinence following prostate treatment. Updates to the guideline include:

“Pre-treatment updates to be more inclusive of patients who will undergo treatments other than radical prostatectomy.

Treatment updates that include new evidence on adjustable balloon devices and the efficacy and outcomes of slings.

New discussion of counseling patients regarding risk factors of artificial urinary sphincter erosion.

New guidance on explanation in patients presenting with infection or erosion of an artificial urinary sphincter or sling.

Updated future directions discussing ongoing research in the field and potential future treatment options,” according to the news release.

These updated statements are reflective of 17 studies that met the criteria for inclusion.

“Incontinence following prostate treatment is a significant concern that profoundly affects the quality of life for many patients. This updated guideline aims to equip clinicians with the latest evidence-based strategies to manage and treat this condition effectively,” said James Quentin Clemens, MD, president of SUFU.

 “By addressing the complexities of post-treatment incontinence, including the impact of radiation and the risks associated with artificial urinary sphincters, we strive to improve patients' outcomes and quality of life.”

In total, 9 guideline statements were updated regarding pre-treatment, treatment options, complications following surgery, and special situations. The AUS Failure Algorithm was also updated to include cystoscopy as a method for determining erosion and worsening of incontinence.

Keith Rourke, MD, FRCSC, president of GURS, concluded in the news release,

 “Despite a decline in [prostate-specific antigen] screening, increased use of active surveillance, and refinements in curative therapies, incontinence remains a profound issue after prostate cancer treatment. The increasing use of radical prostatectomy in patients with high-risk cancer and salvage local therapies has resulted in increased complexity and complication risk in patients presenting with urinary incontinence after prostate treatment. This AUA guideline provides up-to-date, evidence-based recommendations on the best way to evaluate, counsel, stratify, and optimize outcomes for patients with this challenging condition.”

1. American Urological Association releases incontinence after prostate treatment guideline amendment. News release. American Urological Association. June 27, 2024. Accessed July 10, 2024. https://www.auanet.org/about-us/media-center/press-center/american-urological-association-releases-incontinence-after-prostate-treatment-guideline-amendment

2. Incontinence after Prostate Treatment: AUA/GURS/SUFU Guideline. 

. https://www.auanet.org/guidelines-and-quality/guidelines/incontinence-after-prostate-treatment

3. Breyer BN, Kim SK, Kirkby E, Marianes A, Vanni AJ, Westney OL. Updates to Incontinence After Prostate Treatment: AUA/GURS/SUFU Guideline (2024). 

. Published online July 27, 2024. doi:10.1097/JU.0000000000004088

The American Urological Association, along with GURS and SUFU, has updated the guideline for managing incontinence after prostate treatment. This amendment addresses the significant quality of life impact of urinary incontinence post-prostate therapies, including prostatectomy and radiation. The guideline now includes 38 recommendations, with updates on pre-treatment inclusivity, new evidence on treatment devices, and counseling on artificial urinary sphincter risks. It also highlights the importance of addressing complications and future research directions. These updates aim to enhance patient outcomes and quality of life through evidence-based strategies.

The guideline includes 38 recommendations on managing incontinence following treatment for localized prostate cancer or benign prostatic hyperplasia.

AUA, GURS, SUFU amend guideline for incontinence after prostate treatment

, discuss the study, “Development of a Longitudinal Prostate Cancer Transcriptomic and Clinical Data Linkage,”1 for which they served as the lead and senior authors, respectively. Leapman is a urologic oncologist, a prostate cancer clinician, and an associate professor of urology at Yale University School of Medicine, and Sprenkle is a urologic oncologist and an associate professor of urology at Yale University School of Medicine in New Haven, Connecticut.

This transcription has been edited for clarity.

Could you discuss the background and rationale for this study?

 The big picture for this study is that we worked with Veracyte, which is the maker of the Decipher Genomic Profile Test, to begin to understand real-world use of the Decipher Classifier. We teamed up to look at all evidence of Decipher testing based on the centralized records they keep. This is really our first effort to begin to develop a way to understand what happens in the real-world setting. We linked Decipher test results and clinical information with real-world outcomes to begin to understand the key end points in prostate cancer, such as recurrence and metastasis following treatment.

What were the key findings from this study?

 The key findings of this study were that we were able to successfully link over 92,000 individuals who had evidence of Decipher testing with real-world clinical data. The scale of that linkage and the manner with which we were able to do it is really exciting and opens the door for a lot of future discovery. Some of the other findings that are new and notable are that we have to pare that number down when we want to look at certain outcomes. Some individuals are more or less active in the real-world data; they have more or less activity in terms of claims that allow us to identify the downstream outcomes. When we start paring it down to about 58,000 patients who have regular activity in claims, we can identify the metastasis and recurrence outcomes in those individuals and also look based on biopsy-tested and radical prostatectomy-tested samples.

What are the implications of these findings?

 The first step is to begin to look at prognostic associations. We have a publication that should be coming out shortly, and this work has been presented at the [American Urological Association annual] meeting previously, where we looked at, in the real-world setting, in patients who are actually tested as part of their clinical care, are Decipher results associated with those key outcomes, recurrence and metastasis? What we have found is that in both the biopsy- and prostatectomy-tested patients, Decipher was an independent risk factor for developing recurrence or metastasis over time. That's the first step is validating the prognostic association of the test and the clinical outcome.

 The importance of that, too, is that the test was designed in a retrospective cohort. So, they saw that the Decipher test worked by finding people who had certain outcomes, and then seeing what treatment they had gotten in testing their tissue from 10 years previously. This is unique, because this is the first time where people had the test, they then had treatment after the test was done, as Dr. Leapman has mentioned, in the real-world setting. So, this is a true validation in long-term follow-up of people who had to test prospectively, and then were treated. It's a very powerful, unique outcome to be able to talk about.

What future work is planned based on this study?

 We have another publication in process that is looking at those outcomes. This first paper that we're talking about was really talking about the nuts and bolts of how we are assessing those outcomes. Believe it or not, there's a ton of work that goes into that, because if we believe that a certain outcome happened, we want to be confident that it did indeed occur. The next step is to begin looking at clinical outcomes, those recurrence and metastasis and progression events. I think the next phase of discovery is understanding, are there new signatures? Are there new molecular features that we were unable to detect in smaller cohorts that we are able to appreciate at the larger level? As an additional layer, to begin understanding what happened clinically, as a consequence or as a function of having a Decipher test––were differences in management appreciable? Did patients who had a high Decipher test after their prostatectomy get adjuvant radiation? Were patients enrolled in active surveillance? In patient who had high scores, did they get treated? Did they progress faster? There are numerous very practical clinical questions that can be unpacked with a resource like this.

What has been the impact of genomic testing in prostate cancer management? What influence will it continue to have moving forward?

The study explores the real-world application of the Decipher Genomic Profile Test in prostate cancer management, linking test results with clinical outcomes such as recurrence and metastasis. Over 92,000 patients' data were analyzed, revealing Decipher as an independent risk factor for these outcomes. The study validates the test's prognostic value in a real-world setting, marking a significant step in integrating genomic testing into clinical practice. Future research aims to identify new molecular signatures and assess the impact of Decipher on treatment decisions and patient management.

"The scale of that linkage and the manner with which we were able to do it is really exciting and opens the door for a lot of future discovery," says Michael S. Leapman, MD, MHS. 

Barry Kogan, MD

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