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The safety review committee recommended that the phase 2 portion proceed with the 8 GBq dose.

Trial of 64Cu/67Cu-SAR-bisPSMA in mCRPC progresses to dose expansion phase 

The average life expectancy was 80.3 years among men with a total motile sperm count over 120 million, compared with 77.6 years among men with a total motile sperm count ranging from >0 to 5 million.

Study links poor semen quality with shorter life span

The ARID II trial is assessing the safety and effectiveness of the device in men who are scheduled to undergo robotic-assisted radical prostatectomy.

FDA greenlights pivotal trial of Voro Urologic Scaffold for postprostatectomy SUI

The median OS was 34 months with 177Lu-PSMA-617 plus enzalutamide compared with 26 months with enzalutamide alone. 

Adding 177Lu-PSMA-617 to enzalutamide extends OS in mCRPC

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“We felt, not only for the study, but for providing good care, that it was important to try and have these patients follow-up and see if we could identify factors that might impact their follow-up,” says Christina Ching, MD. 

Christina Ching, MD, on study of follow-up after pediatric stone surgery 

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

Jason M. Hafron, MD, CMO, speculates on coming advancements in the field of prostate cancer

Jason Hafron, MD, on key trends that will shape prostate cancer care in 2025

, speculates on coming advancements in the field of prostate cancer. Hafron is the chief medical officer and the medical director of clinical research at Michigan Institute of Urology.

There are so many exciting things going on in research and care in 2025. I'm going to highlight a few key areas that I am excited about, specifically the elevated PSA population and management of elevated PSA or people at risk for prostate cancer. I think what's going to be exciting this year is a serum blood test called IsoPSA. IsoPSA is a very interesting test. It's indicated for men with a PSA above 4 ng/mL and at risk for prostate cancer. It can be used with or without finasteride, so a lot of flexibility there. What's interesting about IsoPSA is that it looks at not only the PSA concentration per se, but at different proteins or different isoforms of PSA in solution that can predict, at a very high level, the likelihood that a patient has significant (grade group 2 or higher) prostate cancer. 

Another big area that we're seeing, and we've seen in last decade, is within prostate cancer. We're seeing a lot of exciting research and a lot of new trends that are going to develop and mature over the year. We have to start off in prostate cancer with PSMA-PET imaging. PMSA-PET imaging is disruptive technology that is improving the quality of care very quickly. What we're seeing is a lot of research being done in PET imaging, looking at new radioisotopes. At the end of last year, there were some publications looking at copper as another isotope and the advantages of using copper for diagnosis. There's a lot of research being done in PET imaging looking at alternative receptors. Currently, most of its PSMA-based, but are there other receptors that can be used for diagnostic or even diagnostic tools? And then [there’s] this concept of covalency. Can we change the interaction at the receptor, prolong that interaction, something you never really want to do in medicine, but something you want to do, potentially, in PET imaging. As we move through 2025, I think we're going to see more and more expansion of new ideas, new isotopes, and possibly improvement in PET imaging for the future.

Another big area that we're seeing changing in prostate cancer is looking at high-risk and very high-risk per NCCN guidelines in prostate cancer. Last year, I was part of a research team that presented the use of apalutamide in patients with high-risk or very high-risk prostate cancer. It was a phase 2 trial, called Apa-RP. In that trial, we gave patients 12 months of apalutamide after prostate cancer [surgery]. We saw a significant signal highlighting potentially that apalutamide in high-risk and very high-risk patients after surgery might be helpful. There are 2 ongoing trials looking in this space. There's the PROTEUS trial that I'm not exactly sure when will read out, but it's an exciting trial because it's looking at apalutamide 6 months before and apalutamide 6 months after surgery to determine if that improves performance, specifically metastasis-free survival in this patient population. If we see a positive trial from PROTEUS, hopefully late this year, that would potentially change the standard of care and be a nice option for these very difficult to treat patients. 

Another area that we're seeing use of adjuvant medication is in radiation therapy. Again, in high-risk, very high-risk patients, if we add apalutamide—this is the ATLAS trial—will this improve outcomes? ATLAS hopefully will report out shortly, but that also could be a have a significant impact on clinical care, specifically the high-risk or very high-risk prostate cancer patient.

Another project that we're working on that we just launched, and we're very excited about, is a project called PC360 or Prostate Cancer 360. This project was developed with Dr. David Crawford and is supported by an educational grant from Tolmar Pharmaceuticals. What we're looking at is, can we use chronic care management to mitigate a lot of the side effects of androgen deprivation therapy? We are just starting the clinical evaluation. We are going to start evaluating whether we can use chronic care management again to lower the risk of cardiovascular disease or cardiac risk or MACE. Can we use chronic care management to improve nutrition within these patients, exercise, depression and all the negative things that we know are associated with androgen deprivation therapy? Can we use this model or this program to improve the care of these patients? So, more to come on that. We're excited about this project for 2025, and we'll see where the results take us.

This transcript was AI generated and edited by human editors for clarity.

“As we move through 2025, I think we're going to see more and more expansion of new ideas, new isotopes, and possibly improvement in PET imaging for the future,” says Jason M. Hafron, MD, CMO.

The FDA has issued class-wide labeling changes for testosterone products based on findings from the phase 4 TRAVERSE trial (NCT03518034) as well as results from required postmarket ambulatory blood pressure monitoring (ABPM) studies.

According to the FDA, the following changes are required based on data from the ABPM studies:

“Adding product-specific information on increased blood pressure for testosterone products with completed ABPM studies; [and]

Adding a new warning about increased blood pressure for testosterone products [that] currently do not have such a warning in their labeling.”

Additionally, the agency is recommending the following changes based on findings from TRAVERSE:

“Adding the results of the TRAVERSE trial to all testosterone products;

Retaining 'limitation of use' language for age-related hypogonadism; and

Removing language from the boxed warning related to an increased risk of adverse cardiovascular outcomes for all testosterone products.”

These changes clarify several prior safety warnings for testosterone products, including a 2014 warning on the reported risks of stroke, heart attack, and death in men taking these products

 and a 2015 decision requiring labeling changes to inform of possible risks when using testosterone products for low testosterone due to aging.

“For years, patients have been unduly apprehensive about testosterone replacement therapy due to the black box warning, leading many to avoid a treatment that could significantly improve their health,” said Shalin Shah, CEO of Marius Pharmaceuticals, in a news release from the company.

 “With the removal of this warning, patients and providers can finally have an informed, evidence-based discussion about the true benefits and risks of [testosterone replacement therapy].”

Testosterone is currently approved for men who lack or have low testosterone levels in conjunction with an associated medical condition.

The postmarket ABPM studies were initiated following premarket studies in 2016 and 2017 that suggested testosterone products (administered via subcutaneous injection and orally) may increase blood pressure. The postmarket studies confirmed these results, showing that testosterone products, class-wide, led to an increase in blood pressure.

The TRAVERSE trial was initiated following a 2014 joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, which convened to discuss reports of stroke, heart attack, and death in men receiving testosterone products.

In total, the trial enrolled and randomly assigned 5204 men to transdermal 1.62% testosterone gel (n = 2601) or placebo gel (n = 2603).

 Patients enrolled were those most vulnerable to an increased risk of adverse cardiovascular outcomes; inclusion criteria included men aged 45 to 80 years who had preexisting or a high risk of cardiovascular disease. Participants also had reported symptoms of hypogonadism and had 2 fasting testosterone levels below 300 ng/dL.

Overall, a cardiovascular event (the first adjudicated major adverse cardiac event) was reported in 7.0% (182) patients in the testosterone arm vs 7.3% (190) in the placebo arm (HR, 0.96; 95% CI, 0.78 to 1.17; 

 < .001 for noninferiority). The investigators also observed “no clinically meaningful difference” between the 2 cohorts in the incidence of a secondary cardiovascular end point, which was defined as “the first occurrence of any component of the composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization.”

The incidence of pulmonary embolism was higher in the testosterone group, occurring in 0.9% of patients in the treatment arm vs 0.5% in the placebo arm. Patients in the treatment arm also experienced a higher incidence of atrial fibrillation and acute kidney injury.

Overall, the authors concluded, “In men with hypogonadism and preexisting or a high risk of cardiovascular disease, testosterone-replacement therapy was noninferior to placebo with respect to the incidence of major adverse cardiac events.”

1. FDA issues class-wide labeling changes for testosterone products. News release. FDA. February 28, 2025. Accessed March 3, 2025. https://www.fda.gov/drugs/drug-safety-and-availability/fda-issues-class-wide-labeling-changes-testosterone-products

2. FDA Drug Safety Communication: FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products. News release. FDA. January 31, 2014. Accessed March 3, 2025. https://wayback.archive-it.org/7993/20161022203724/http:/www.fda.gov/Drugs/DrugSafety/ucm383904.htm

3. FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use. News release. FDA. March 3, 2015. Accessed March 3, 2025. https://wayback.archive-it.org/7993/20161022203711/http:/www.fda.gov/Drugs/DrugSafety/ucm436259.htm

4. Marius Pharmaceuticals helps drive FDA’s landmark testosterone label update, removing black box warning. News release. Marius Pharmaceuticals. March 3, 2025. Accessed March 3, 2025. https://www.globenewswire.com/news-release/2025/03/03/3035638/0/en/Marius-Pharmaceuticals-Helps-Drive-FDA-s-Landmark-Testosterone-Label-Update-Removing-Black-Box-Warning.html

5. Lincoff AM, Bhasin S, Flevaris P, et al. Cardiovascular safety of testosterone-replacement therapy. 

. 2023;389(2):107-117. doi:10.1056/NEJMoa2215025

The FDA has mandated class-wide labeling changes for testosterone products following findings from the TRAVERSE trial and post-market ambulatory blood pressure monitoring studies. These changes include adding product-specific information on increased blood pressure, a new warning for products lacking such a warning, and incorporating TRAVERSE trial results. The TRAVERSE trial demonstrated that testosterone-replacement therapy was noninferior to placebo regarding major adverse cardiac events, though it showed a higher incidence of pulmonary embolism, atrial fibrillation, and acute kidney injury in the testosterone group.

The FDA is requiring a warning about increased blood pressure and is recommending that the black box warning related to the increased risk of adverse cardiovascular events be removed.

FDA issues labeling changes for testosterone products following TRAVERSE, postmarket studies

The target enrollment has been met in the pivotal VAPOR 2 trial (NCT05683691), assessing the safety and efficacy of the Vanquish water vapor ablation device in patients with intermediate-risk, localized prostate cancer, Francis Medical, Inc, announced in a news release.

In total, the trial enrolled 235 patients across 26 clinical trial sites in the US. All patients enrolled in the study have completed their initial treatment.

"We are thrilled to announce the completion of enrollment in the VAPOR 2 study ahead of our expected timeline," said co-principal investigator Samir Taneja, MD, of NYU Langone Health, in the news release.

 "For a study of this scale to finish enrollment early is a remarkable achievement and speaks to the dedication of our participating investigators and the level of excitement surrounding this promising technology."

Overall, the prospective, multicenter, single-arm VAPOR 2 study is assessing the safety and efficacy of Vanquish in adult patients with Gleason grade 2 prostate cancer.

 Those enrolled in the study will receive transurethral delivery of water vapor ablation.

To be eligible for enrollment, patients needed to be at least 50 years of age and have a life expectancy of at least 10 years. Participants must also have a prostate size between 20 cc and 80 cc, a prostate-specific antigen level of 15 ng/mL or lower, and a cancer stage less than or equal to T2c, among other requirements.

The primary effectiveness end point is freedom from systemic disease, systemic therapy, salvage therapy, and a Gleason grade group of 2 or higher at 36 months. The primary safety end point is the proportion of patients who are free from new or worsening urinary incontinence at 12 months. A key secondary end point of the trial is the proportion of patients who are free from impotence at 36 months.

Patients in the study will continue to be followed for up to 5 years to assess long-term outcomes. Primary completion of the trial is expected in April 2027.

According to Francis Medical, the Vanquish device is “designed to use phase shift energy stored in sterile water vapor to convectively transfer thermal energy to cancerous tissue, causing cell death.” The FDA granted a breakthrough therapy designation to the device in August 2023.

®, co-investigator Arvin K. George, MD, of Johns Hopkins Medicine, Baltimore, Maryland, explained how this technology has been replicated from what is currently being done in the management of benign prostatic hyperplasia (BPH) with Rezum treatment.

“It's essentially the same treatment modality, using steam or water vapor and using convection rather than conduction to be able to treat prostate cancer or prostate tissue,” George explained. “It has been redesigned to be able to perform the treatment directionally, meaning that we can get the water vapor or steam exactly where we want it within the prostate under image guidance or ultrasound MRI guidance.”

Francis Medical also noted that results from the VAPOR 2 trial will support a submission to the FDA for 510(k) clearance of the device. The company expects to file the application with the agency in July 2025.

1. Francis Medical announces completion of enrollment in the VAPOR 2 pivotal study for Vanquish prostate cancer treatment. News release. Francis Medical Inc. February 25, 2025. Accessed February 26, 2025. https://www.francismedical.com/completion-of-vapor-2-enrollment-for-vanquish-prostate-cancer-treatment/

2. Water vapor ablation for localized intermediate risk prostate cancer (VAPOR 2). ClinicalTrials.gov. Updated January 8, 2025. Accessed February 26, 2025. https://clinicaltrials.gov/study/NCT05683691

3. Francis Medical receives U.S. FDA Breakthrough Device Designation for Vanquish minimally invasive prostate cancer therapy. News release. Francis Medical Inc. August 1, 2023. Accessed February 26, 2025. https://www.francismedical.com/press-release-francis-medical-receives-fda-breakthrough-device-designation-for-vanquish/

The VAPOR 2 trial has successfully completed enrollment, assessing the Vanquish Water Vapor Ablation device for intermediate-risk, localized prostate cancer. The study enrolled 235 patients across 26 US sites, with all participants having completed initial treatment. The trial evaluates the device's safety and efficacy, with primary endpoints including freedom from systemic disease and urinary incontinence. The Vanquish device uses phase shift energy in water vapor to target cancerous tissue. Results will support an FDA 510(k) clearance application, expected in July 2025, with primary trial completion in April 2027.

Data from the VAPOR 2 trial are intended to support a submission to the FDA for 510(k) clearance of the device.

Enrollment goal met in trial of Vanquish device for localized prostate cancer

Standard of Care and Intravesical Chemotherapy in NMIBC

How do you use guidelines to treat patients with NMIBC?

Where are you using intravesical chemotherapy in your patients with NIMBC?

Experts discuss the standard of care and the use of intravesical chemotherapy in the treatment of non–muscle-invasive bladder cancer (NMIBC).

Christina B. Ching, MD

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