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Articles

“Five years after telehealth suddenly became a routine part of care for most Americans, we show that it has not led to runaway utilization or spending. This kind of in-depth analysis can inform its future," says Chad Ellimoottil, MD, MS. 

Data refute concerns about telehealth as Congress weighs legislation 

The detection rate ranged from 44% to 58% on day 0 and 58% to 80% on day 1.

64Cu-SAR-bisPSMA shows efficacy in detection of biochemically recurrent prostate cancer 

“What we hope overall is that this is a biological study that might inform therapeutic development for this disease,” says David A. Braun, MD, PhD.

Identifying unique therapeutic targets for chromophobe kidney cancer

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 

Urology Times is the leading resource for urologists & allied health professionals offering clinical analysis, policy perspectives, & practical advice.

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Authors

Dr. Kaplan, a member of the Urology Times Editorial Council, is E. Darracott Vaughan Jr. Professor of Urology at Weill Cornell Medical College and and director of the Iris Cantor Men’s Health Center, New York Presbyterian Hospital, New York.

"LUTS is an important health care burden, and health care professionals should be screening for its presence in men at risk," writes Steven A. Kaplan, MD.

LUTS’ burden may extend to cardiac events

The management of BPH has had an interesting roller coaster ride over the past 25 years with new medicines, minimally invasive surgical therapies, and a host of novel surgical technologies, including lasers and bipolar electrosurgery.

New tech may bring exciting era in BPH

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

 shares takeaways from his 2024 LUGPA Annual Meeting presentation, “Five things urologists need to know now about bladder and kidney cancer in 2025.” Jayram is a urologic oncologist and director of the Advanced Therapeutics Center in Nashville, Tennessee.

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

You gave a presentation titled, "Five things urologists need to know about bladder and kidney cancer in 2025." Could you highlight some key takeaways from that session?

So much is happening; I tried to try to slow down and put some focus on some things that were most important. We talked a little bit about what's happening in intermediate-risk [bladder cancer]. A lot of the attention has been in high-risk disease, but intermediate-risk disease, I think, is kind of a more practical and a more popular disease state for a community urologist, because these are patients with lower grade disease. They come back fairly often. We're not really that threatened by them in terms of dying from their cancer, but it still is a big nuisance disease, and it's still a big quality-of-life issue. And so ultimately, there's so much happening with new drugs and new therapies coming in intermediate-risk disease, there's going to be a lot of questions of, "well, do we really need to treat all of these patients now with all of this stuff? Because I haven't been treating any patients with this stuff." So we tried to lay out a couple reasons why and who you should treat with intermediate-risk disease and what potentially those treatments could look like in the future.

We then talked a little bit about BCG-unresponsive disease, which is a really hot topic; a lot of trials and a lot of data are coming there. We outlined the 4 therapies that if we had to choose today for BCG-unresponsive carcinoma in situ that are available to urologists [as well as] the pros and cons of all of them.

I then talked a little bit about muscle-invasive disease, which is again aggressive disease, which usually requires major treatments. There have been a lot of advances in terms of new trials, new therapies that are coming out that potentially can change how we look at these patients, utilizing ctDNA as a marker for how to treat patients, how to prognosticate, how patients do on treatment.

And then we moved to kidney cancer. One really important thing that urologists need to know is that adjuvant treatment for high-risk renal cell carcinoma is now here to stay. It's cemented by overall survival data that we haven't had with any of the other treatments. So patients who have a nephrectomy for high-risk renal cell [carcinoma] should get consideration for immunotherapy either if the urologist is giving it, or a medical oncologist. But the bottom line is, they should be getting that.

And then the PET scan that that is now emerging for clear cell kidney cancer, which is called girentuximab or CAIX, is really exciting. It's kind of paralleling what we're seeing with PSMA in terms of its expression, its uptake, and its really high sensitivity and specificity for kidney cancer. That's something we really need in this space, because our imaging for kidney cancer is okay, but it leaves a lot of questions, and it causes a lot of follow-up procedures and visits to be done. And I think a tool like this could really, really change how we're thinking about kidney cancer.

There have been a lot of major advances in bladder cancer, specifically in the non–muscle-invasive space. Could you highlight some of the recently approved agents?

You have nadofaragene firadenovec [Adstiladrin], which has been out now for a year or 2. It's intravesical gene therapy with interferon. It's once every 3 month dosing. And now we're starting to get a good balance of data and information about it. A lot of urologists are using it and feel really comfortable with it, and it's really friendly to patients in terms of the dosing schedule, and it's easy to give in your practice. So that's something that I think has caught on and people are pretty happy with.

Pembrolizumab [Keytruda] was approved a few years ago. We've had some discussions about systemic therapy only in this space has limitations because of the side effects, and also the data aren't super strong, so most people are looking more at combination therapy for that, instead of just using pembrolizumab. And then we have an Anktiva [nogapendekin alfa inbakicept], which was just recently approved. It's an IL-15 agonist that stimulates natural killer cells to really mount an immune response, and I think that that's really exciting. We still are super early in the whole process, so there are a lot of things that need to be figured out, but a lot of groups that are giving some of these other therapies, of course, are going to look at that as well. There are some differences in terms of how these drugs are handled and stored. The economics of these drugs are a little bit different. All of that's going to be an important part of how we pick these therapies and how patients pick these therapies.

Are there any other agents that you're looking forward to seeing in the future?

There is a lot of trial activity going on with immunotherapy. Specifically with immunotherapy, we have BCG combination trials, BCG plus sasanlimab, BCG plus durvalumab, with a couple trials that are going to read out in the next 12 months. That's going to be really exciting to see if the BCG-naive population can benefit from combination treatment, and who would benefit the most, and then the other side of it are some of these other agents. Cretostimogene grenadenorepvac has a really robust trial platform, and that's intravesical gene therapy as well that has really good data and has a lot of interesting applications, I think, in patients with both intermediate-risk disease, BCG-unresponsive disease, and patients with carcinoma in situ. And so I think that that those trials are continuing to accrue or get more information. And then you have other players that are in a little bit earlier stages, Protara with [TARA-002], which is an intravesical agent. You have enGene, which is a non viral vector, intravesical agent that has a lot of promise and could be really easy to give for a community center. Those studies are still accruing. That data is still being accumulated. But there's a ton of activity in this space, and I think every 6 to 12 months, we're going to going to keep getting these boluses of information that's going to help us.

Are there any challenges or opportunities that come with all of these new agents being available?

Yes. People are going to ask, "how do I pick? What do I use? What what goes first? What comes second?" There's going to be an art to this, if you will. But the way I see it is, put everything in the toolbox and see what you can use, which is better than not having anything in the toolbox. But yes, there's going to be mechanism-of-action concerns. You're not going to want to give gene therapy multiple times to the same patient. There's cytotoxic therapy with gem-doce, or the pretzel. You're going to have a lot of of options. And there is going to be some concern about how to sequence them A to Z, and really, it's going to come down to ease of use and how your clinic can operationalize this, because what we've realized is that our centers are different than hospital systems. They're different than academic centers. We have different infrastructure; we have different legislation and state-specific regulations. And so at some point, you're going to have to just go with what's easiest for you to give and that's that's going to be a big part of all this.

The discussion highlights significant advancements in bladder and kidney cancer management, emphasizing the importance of understanding intermediate-risk bladder cancer and BCG-unresponsive disease. New therapies and trials are reshaping treatment paradigms, including the use of ctDNA in muscle-invasive bladder cancer and adjuvant immunotherapy for high-risk renal cell carcinoma. Emerging imaging techniques, such as girentuximab PET scans, promise improved diagnostic accuracy for kidney cancer. The introduction of novel agents like nadofaragene firadenovec and Anktiva, alongside ongoing immunotherapy trials, presents both opportunities and challenges in treatment selection and sequencing.

"We...talked a little bit about BCG-unresponsive disease, which is a really hot topic; a lot of trials and a lot of data are coming there," says Gautam Jayram, MD.

Gautam Jayram, MD, on the top 5 things to know in bladder and kidney cancer

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.

“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.

Steven A. Kaplan, MD

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