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In February 2025, the FDA recommended a removal of the black box warning related to an increased risk of adverse cardiovascular outcomes for all testosterone products. This recommendation has important implications for urologists and the patients they treat.

Label change for testosterone: Implications for urologists, prescribers, and patients

At week 12, patients in the URO-902 cohorts demonstrated significantly greater improvements in daily microuritions vs placebo.

Gene therapy shows encouraging efficacy for overactive bladder

"For every 1 unit increase in whole body tumor SUVmean, there was a 12% decrease in the risk of an rPFS event and a 10% decrease in the risk of death," says Phillip H. Kuo, MD, PhD, FACR.

Baseline 68Ga-PSMA-11 PET/CT parameters can predict response to 177Lu-PSMA-617

"This finding reinforces PROSTOX ultra as a true measure of the biological response to radiation, independent of treatment era or technique that can identify the safest course of treatment to avoid toxicity," says Amar U. Kishan, MD. 

Genetic test can predict risk of toxicity following radiation for prostate cancer

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“There exists compelling evidence to suggest smoking and drinking alcohol can have a dramatic impact on male and female reproductive potential,” write Premal Patel, MD, and Ranjith Ramasamy, MD.

How do smoking and drinking affect fertility?

Dr. De La Cerda provides an overview of a patient case involving a 68 year-old male presenting with severe back pain, with an analysis of the clinical presentation, workup, and medical history.

Bone Predominant mCRPC Patient Case

Video content above is prompted by the following:

What are your initial impressions of the case?

Video Series

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

The PROSTOX ultra test, which consists primarily of microRNA single-nucleotide polymorphisms (mirSNPs), demonstrated the ability to predict which patients may experience late-grade genitourinary (GU) toxicity following radiation treatment for prostate cancer.

"These findings represent a very important moment in the treatment of prostate cancer and for the field of oncology treatment as a whole," said senior author Joanne B. Weidhaas, MD, PhD, a professor at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA); head of translation research in the Department of Radiation Oncology; and co-founder of MiraDx and founder of MiraKind, in a news release on the findings.

 "While tumor-based molecular profiling tests that inform treatment selection have contributed to improved patient outcomes, no tests based on germline genetics currently exist to identify toxicity risks to treatment. PROSTOX ultra is the first test that predicts radiation toxicity, giving patients and their physicians important information to make decisions that balance effectiveness with long-term quality of life.”

For the study, the investigators assessed data from the phase 3 MIRAGE trial (NCT04384770), which assessed the use of aggressive margin reduction with MRI-guided stereotactic body radiotherapy (SBRT) to standard CT-guided SBRT. The current study included data from 148 patients.

Overall, the PROSTOX ultra test accurately predicted which patients in that trial would experience late grade 2 or greater GU toxicity, with an area under the curve (AUC) of 0.762. In the MRI- and CT-guided arms, the AUC was 0.762 and 0.761, respectively.

The test also demonstrated a sensitivity of 0.576 and a specificity of 0.948 in this cohort. Compared with data from the original training set, the sensitivity was lower (original set, 0.714) and the specificity was similar (original set, 0.924) in the MIRAGE cohort.

The authors noted, “While it should be acknowledged that the sensitivity of PROSTOX was lower in this study than in the original cohort, this could be explained by the use of a different toxicity scoring systems (CTCAE [Common Terminology Criteria for Adverse Events] vs RTOG [Radiation Therapy Oncology Group]), as well as [the] inclusion of pelvic lymph nodes and ADT in this validation study.”

When the investigators used numeric outputs for PROSTOX (as opposed to binary cutoff values), the AUC of PROSTOX was 0.83 in the MRI group and 0.71 in the CT group. A higher PROSTOX score was also correlated with a higher GU toxicity grade overall (lin reg 

 = 1.2E-9) as well as in the MRI group (lin reg 

The authors then used Gene Ontology (GO) analyses to identify unique pathways associated with acute, chronic, and late toxicity.

“Here we found that acute only and chronic GU toxicity have unique mirSNP-based genetic signatures, and that all 3 forms of toxicity have gene pathway alterations based on GO analyses that differentiate them from each other,” the authors wrote.

According to the authors, these findings support the potential of mirSNPs to predict toxicity and “to act as a path for the continued personalization of RT with improved patient outcomes.”

“Advancements in radiation technology, treatment planning, patient care, and follow-up make it challenging to directly compare toxicity between older and more modern treatment approaches,” explained lead author Amar U. Kishan, MD, a radiation oncologist at UCLA, in the news release.

 “Despite these challenges, this study validated PROSTOX ultra as a predictive biomarker, and that a genetic predisposition to increased toxicity persists with modern, high-precision SBRT, including MRI-guided SBRT. This finding reinforces PROSTOX ultra as a true measure of the biological response to radiation, independent of treatment era or technique that can identify the safest course of treatment to avoid toxicity.”

1. Kishan AU, McGreevy K, Valle L, et al. Validation and derivation of microRNA-based germline signatures predicting radiation toxicity in prostate cancer. 

. Published online April 7, 2025. doi:10.1158/1078-0432.CCR-24-3951

2. MiraDx announces new study published in Clinical Cancer Research validating PROSTOX ultra diagnostic test for predicting radiation-induced late toxicity in prostate cancer. News release. MiraDx. April 7, 2025. Accessed April 7, 2025. https://www.businesswire.com/news/home/20250404130675/en/MiraDx-Announces-New-Study-Published-in-Clinical-Cancer-Research-Validating-PROSTOX-ultra-Diagnostic-Test-for-Predicting-Radiation-Induced-Late-Toxicity-in-Prostate-Cancer

The PROSTOX ultra test, utilizing microRNA single-nucleotide polymorphisms (mirSNPs), effectively predicts late-grade genitourinary toxicity in prostate cancer patients post-radiation therapy. This test marks a significant advancement in oncology, being the first to predict radiation toxicity based on germline genetics, aiding in treatment decisions that balance efficacy and quality of life. The study, part of the phase 3 MIRAGE trial, demonstrated the test's predictive accuracy with an AUC of 0.762. Gene Ontology analyses revealed distinct genetic signatures for different toxicity forms, supporting personalized radiation therapy.

, shares in-depth insights into the study, “Perioperative outcomes of neoadjuvant (neoadj) TAR-200 plus cetrelimab (CET) or CET alone in patients (pts) with muscle-invasive bladder cancer (MIBC) ineligible for or refusing neoadj cisplatin-based chemotherapy (NAC),” which was recently presented at the 40

 Annual European Association of Urology (EAU) Congress in Madrid, Spain.

Necchi is a professor of medical oncology at Vita-Salute San Raffaele University and the director of GU oncology at San Raffaele Hospital in Milan, Italy.

Could you describe the background/rationale for this study? What previous data have been reported?

SunRISe-4 is part of the platform of SunRISe studies that are targeting early bladder cancer, including non–muscle invasive disease and muscle-invasive disease. In particular, SunRISe-4 is targeted to patients diagnosed with the muscle-invasive tumor, so T clinical—T2-T4a N0M0 muscle-invasive bladder cancer with pure or predominant urothelial cancer histology.

SunRISe-4 is a randomized phase 2 study evaluating TAR-200, which is a gemcitabine-releasing system into the bladder, plus cetrelimab, a checkpoint inhibitor and anti-PD-1 agent, in patients scheduled for radical cystectomy and who are also ineligible for or refuse cisplatin-based chemotherapy. [There are] 2 parallel arms: TAR-200 and cetrelimab in arm A and cetrelimab monotherapy in arm B. It's not actually a comparative study. These 2 arms are not intended to provide a formal, statistical comparison of the efficacy outcomes but are parallel arms. The design is aimed to provide a descriptive analysis of the outcomes in both arms.

In [the] interim analysis that I presented at ESMO [the European Society for Medical Oncology Congress] a few months ago, neoadjuvant TAR-200 and cetrelimab showed a higher pathological complete response (pCR) rate, as high as 42%, and pathological objective response (pOR), meaning downstaging to non–muscle invasive disease, of 62% in the ITT population. In the cetrelimab arm, these proportions were 23% and 36%. There was an enrichment in particular in pCR and pOR in patient presenting with the clinical t2 stage. Based on various secondary assessments, like, for example, the exposure to TAR-200 [of] those patients. The majority [of patients who] were able to receive the 4 doses of neoadjuvant TAR-200 benefited the most in terms of pCR from the neoadjuvant therapy.

Most of the adverse events provided at the interim analysis were grade 1 and 2 and were mostly confined to urinary events. So, nothing really major and nothing very concerning with regard to systemic [adverse events].

What were the key findings presented at EAU?

The analysis that was presented very nicely by Sarah Psutka, MD, at the EAU meeting [was] focused on the surgical safety and surgical outcomes. We are still dealing with an interim analysis subset and not the full study accrual. The patients who were evaluated were 50 patients in the combination therapy arm and 26 radical cystectomies in the cetrelimab monotherapy arm. In general, the patient characteristics were pretty much in line with those already presented with the interim analysis at the ESMO meeting.

Importantly, the main safety parameters that were represented—changes in body mass index, changes in albumin level, changes in creatinine, changes in hemoglobin level—were not significant pre- and post-therapy. Other very important safety parameters, such as the median time to radical cystectomy, were [generally] in line with the safety boundaries, being 13.6 weeks in the TAR-200/cetrelimab arm and 12.4 weeks in the cetrelimab monotherapy arm. So, the treatment was pretty much safe in both arms.

With regard to the overall grade 3 and 4 [adverse] effects, they were reported in 42% of the combination therapy arm patients and 41% in the cetrelimab monotherapy [arm patients]. Again, most of these [adverse events] were not preventing the continuation of therapy, preventing cystectomy, or exposing the patient to an extra toxicity, but were primarily confined to local [adverse events]. With regard to the distribution between robotic and open cystectomy, there was nothing major to say. The data were pretty much in line with what is happening in standard practice.

The only missing point is to look at the entire dataset [to] confirm these findings with regard to efficacy and safety in the interim analysis. The study is accrued, and we are still waiting for the finalized subset, so we'll see if there will be any change. Very small changes are expected, with regard to both efficacy and safety, in my opinion.

Based on these initial findings, what is the overall take-home message for urologists?

We can target the MIBC treatment with a different modality as compared with what we were used to in the recent past. Looking at the combination of intravesical therapy and systemic therapy may provide us and may provide the patient with an opportunity of achieving sustained responses, while preserving most of the [adverse] effects that are usually provided by aggressive systemic therapy, meaning chemotherapy or maybe in the near future, an [antibody-drug conjugate] and [immunotherapy] combination.

We have a snapshot of the safety data from different approaches, such as the NIAGARA approach—the immune therapy and chemotherapy combination. The safety data from NIAGARA is in line with the chemotherapy data. So, nothing exceedingly higher than the literature. But the quality of the 40% to 45% of grade 3/4 [adverse] effects that have been reported in NIAGARA is different from the quality of [adverse events] reported in SunRISe-4, mainly being represented by systemic [adverse events]. We are shifting the landscape toward something that is maybe more manageable for the patient. Provided that we will confirm the efficacy data long-term, there is an opportunity to spare, de-escalate a bit, the treatment in select patients, and to expose the patient with inferior risk of developing severe [adverse] effects.

Is there anything else that you’d like to add?

The natural evolution for SunRISe-4, provided that there would be a validation of pathological response findings, is to fine-tune the selection of the patients, trying to select the patients for whom the pCR rate rises to above 50%, such as clinical T2 patients, or maybe [using] biomarkers. We are still waiting for biomarkers from SunRISe-4. If we're able to get this point, to overcome the 50% pCR bar in select patients from SunRISe-4, there would be an opportunity to think about bladder-sparing approaches as the next step. [We could] provide maybe an IO and then reintravesical therapy with the aim to spare the bladder in patients who respond completely at the clinical evaluation after treatment as compared to the baseline situation.

SunRISe-4 is a phase 2 study evaluating TAR-200 and cetrelimab in muscle-invasive bladder cancer patients ineligible for cisplatin-based chemotherapy. The study showed promising pathological complete response rates, particularly in clinical T2 stage patients. Adverse events were mostly mild and localized. Surgical safety outcomes were favorable, with no significant changes in key safety parameters. The study suggests a potential shift towards more manageable treatment modalities, combining intravesical and systemic therapies. Future directions include refining patient selection and exploring bladder-sparing approaches based on biomarker validation.

"Provided that we will confirm the efficacy data long-term, there is an opportunity to spare, de-escalate a bit, the treatment in select patients, and to expose the patient with inferior risk of developing severe [adverse] effects," says Andrea Necchi, MD.

Perioperative outcomes support benefit of TAR-200 plus cetrelimab in MIBC

The FDA has granted 510(k) clearance to the Glean Urodynamics System for adult patients with lower urinary tract dysfunction (LUTD), Bright Uro announced in a news release.

According to the company, the system is a “urodynamic analyzer system that is intended to quantify the pressure and flow characteristics of the lower urinary tract.” The device enables wireless, catheter-free ambulatory urodynamics monitoring that can aid decision-making for LUTD.

“I consider Glean to be the kind of diagnostic technology advance that the urology community has awaited for decades,” said Alan J. Wein, MD, of the University of Miami, Florida, in the news release.

 “The system produces information that is closer to a real-life situation than that generated in a urodynamics laboratory. New norms may have to be worked out, but ultimately, I think this has great potential for deciphering lower urinary tract symptomatology and thereby improving patient care.”

Bright Uro shared that the Glean System was found to be easier for clinicians to use, delivered more accurate data, and was more comfortable for patients.

 the company explained, “The Glean system consists of an insertion tool, a Bluetooth-enabled pressure sensor in a flexible silicone tube, a software app for use by clinicians and patients, and a uroflowmeter to sense volume and flow.”

Bright Uro also explained that the catheter-free design of the system may enable clinicians to collect more ambulatory data with greater physiologic accuracy compared with current standard-of-care options.

“The majority of urologists, including myself, believe that current urodynamics testing is lacking," said Bilal I. Chughtai, MD, of Northwell Health in Syosset, New York.

 “With artificial filling and voiding with catheters in place, patients are often unable to replicate symptoms during the test. Urodynamics is uncomfortable for patients, sometimes even traumatic. Glean will enable patients to void naturally, without catheters in place. I believe this advance will yield a better test that mimics actual symptoms.”

The Glean Urodynamics System was developed by investigators from the Cleveland Clinic, in collaboration with teams from the Department of Veterans Affairs, Case Western Reserve University, and Parker Hannifin Corporation. Bright Uro now holds an exclusive licensing agreement for the technology.

“Today, some providers [forgo] urodynamics due to a paucity of equipment and trained nurses to administer the test,” said Melissa R. Kaufman, MD, PhD, FACS, of Vanderbilt University in Nashville, Tennessee.

 “Given the simple and versatile nature of how Glean is delivered, we’ll be able to accelerate access so more patients can benefit from this important diagnostic information.”

1. Bright Uro receives FDA clearance for Glean Urodynamics System. News release. Bright Uro. April 2, 2025. Accessed April 2, 2025. https://www.businesswire.com/news/home/20250402777960/en/Bright-Uro-Receives-FDA-Clearance-for-Glean-Urodynamics-System

2. Bright Uro launches with $6 million in seed financing and grant from National Institutes of Health. News release. June 9, 2022. Accessed April 2, 2025. https://www.businesswire.com/news/home/20220609005264/en/Bright-Uro-Launches-with-%246-Million-in-Seed-Financing-and-Grant-from-National-Institutes-of-Health

The Glean Urodynamics System, developed by Bright Uro, has received FDA 510(k) clearance for use in adult patients with lower urinary tract dysfunction (LUTD). This innovative system offers wireless, catheter-free ambulatory urodynamics monitoring, providing more accurate and comfortable testing compared to traditional methods. The system's design allows for natural voiding, potentially improving diagnostic accuracy and patient care. Developed in collaboration with the Cleveland Clinic and other institutions, the Glean System aims to enhance access to urodynamics testing by simplifying the process and reducing the need for specialized equipment and personnel.

"Glean will enable patients to void naturally, without catheters in place. I believe this advance will yield a better test that mimics actual symptoms," says Bilal I. Chughtai, MD. 

FDA grants 510(k) clearance to Glean Urodynamics System

Data from the phase 3 TALAPRO-2 trial (NCT03395197) showed that the combination of enzalutamide (Xtandi) plus talazoparib (Talzenna) led to a statistically significant and clinically meaningful improvement in overall survival (OS) vs enzalutamide alone in patients with metastatic castration-resistant prostate cancer (mCRPC).

 These data were recently presented at the 

2025 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium

, shares the OS results in patients stratified by HRR gene mutation status. Overall, both HRR mutation-negative and HRR mutation-positive patients demonstrated an improvement in OS with the combination vs enzalutamide alone, though the benefit was more pronounced in those who had HRR mutations.

Agarwal is professor of medicine and the director of the genitourinary oncology program at the Huntsman Cancer Institute of the University of Utah in Salt Lake City.

Neeraj Agarwal, MD, FACS, shares the OS results in patients stratified by HRR gene mutation status. 

Neeraj Agarwal, MD, on talazoparib/enzalutamide efficacy by HRR gene mutation status

In the subgroup analysis, the addition to talazoparib improved OS in patients who were HRR-deficient (n = 169; HR, 0.549; 95% CI, 0.364–0.826; 

= .0035) and in patients who were HRR–non-deficient/unknown (n = 636; HR, 0.878; 95% CI, 0.713–1.080; 

According to Agarwal, in the patients who did the not have HRR mutations, the OS was 46.6 months in the combination arm vs 37.4 months in the enzalutamide alone arm. Among those who did have HRR mutations, the OS was 45 months in the combination arm vs 31 months in the enzalutamide alone arm.

Agarwal concluded, “These are all meaningful improvement in survival, although survival advantage is more in patients who had HRR gene mutations. That’s why we should continue to obtain comprehensive genomic profiling or NGS testing for all patients with metastatic prostate cancer.”

1. Agarwal N, Azad A, Carles J, et al. Final overall survival (OS) with talazoparib (TALA) + enzalutamide (ENZA) as first-line treatment in unselected patients with metastatic castration-resistant prostate cancer (mCRPC) in the phase 3 TALAPRO-2 trial. 

. 43, 2025 (suppl 5; abstr LBA18). doi:10.1200/JCO.2025.43.5_suppl.LBA18

"We see the overall survival, whether it is [in] all-comers, in HRR gene mutation-positive patients, or in HRR gene [mutation]-negative patients or [those] who did not have mutations, the overall survival is about 45 to 47 months," says Neeraj Agarwal, MD, FACS. 

Premal Patel, MD

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