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Benjamin P. Saylor is associate editor of Urology Times, an Advanstar Communications publication.

Articles

For the trial, a biomarker will be utilized to aid in patient selection for the treatment.

FDA and EMA authorize phase 3 trial of masitinib for mCRPC

The application is supported by data from the phase 3 AMPLITUDE trial.

Expanded indication sought for niraparib plus AAP in Europe

Take a look through all the regulatory milestones in urology from the first half of the 2025.

Regulatory recap: FDA approvals in urology from the first half of 2025

Catch up on exclusive videos you may have missed from the first half of the year.

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Clinical Focus

Pearls & Perspectives, with Amy Pearlman, MD

Pearls & Perspectives: Helen Bernie, DO, MPH, at AUA 2025

, host Amy Pearlman, MD, sits down with Helen Bernie, DO, MPH, at the 

American Urological Association's (AUA) 2025 Annual Meeting

 in Las Vegas for an in-depth discussion on some of the biggest questions facing men’s health and urology today.

Bernie, Director of Male Sexual and Reproductive Medicine at Indiana University, discusses her team’s impressive research output, including 10 abstracts presented at AUA. She offers an inside look at the year-long, collaborative process behind their studies, emphasizing the critical role of dedicated research fellows, medical students, and multi-institutional collaborations.

The conversation shifts to  research on the safety of testosterone therapy in men with prostate cancer. Bernie and Pearlman explore how traditional thinking is evolving, highlighting new data that supports continuing testosterone therapy even during prostate cancer diagnosis, surgery, and recovery—challenging long-held fears and offering patients better quality of life. Both stress the importance of early conversations with urologic and radiation oncologists to ensure shared decision-making that centers patient wellbeing.

The episode also delves into clomiphene use in men and its impact on lipid profiles. Bernie shares insights from her practice, explaining how routine lipid and hormone panels can uncover hidden cardiovascular risks in young men presenting for issues like erectile dysfunction or infertility. She underscores the need for a broader, more preventive approach to men's health, rather than simply treating isolated symptoms.

Finally, they discuss the real-world challenges of oral testosterone therapy. Bernie explains findings from a phase 3 study suggesting that starting at higher doses could minimize lab monitoring burdens, reduce treatment delays, and improve patient satisfaction — a critical point for busy clinicians managing testosterone therapy in large practices.

Relevant disclosures for Pearlman include Boston Scientific Corporation. Relevant disclosures for Bernie include Boston Scientific and Coloplast.

Helen Bernie, DO, MPH, joins the show to discuss data from her Indiana University team from the floor at AUA 2025. 

, discusses the need to increase diversity in clinical trials, specifically focusing on studies in prostate cancer. He also highlights the recent Northwestern-led course, “Enhancing Recruitment of Ethnic Minorities in Cancer Clinical Trials,” which took place on February 16, 2024. Murphy is a urologist at Northwestern University Feinberg School of Medicine in Chicago, Illinois.

During the discussion, Murphy provides some advice for researchers looking to increase diversity in their trials. He also references a study in which 64% of Black patients indicated that they would be willing to discuss clinical trials in prostate cancer, compared with 82% of White patients.

 While there is a difference, Murphy notes that the percentage of more than half of Black patients being willing to discuss clinical trials is not insignificant, and the data supports the idea of clinicians continuing to make the ask to their patients in order to help increase diversity in prostate cancer trials.

Murphy ends the discussion by sharing some of his thoughts on future work building on the Northwestern-led course, such as a session focused on mock recruitments with patients who have previously enrolled in clinical trials.

Don’t forget to subscribe to Speaking of Urology® on 

, or anywhere that podcasts are available.

1. Senft N, Hamel LM, Manning MA, et al. Willingness to discuss clinical trials among Black vs White men with prostate cancer. 

. 2020;6(11):1773-1777. doi:10.1001/jamaoncol.2020.3697

In this podcast episode, Adam B. Murphy, MD, MBA, MSCI, discusses the need to increase diversity in clinical trials, specifically focusing on studies in prostate cancer.

Dr. Murphy on increasing diversity in cancer clinical trials 

On an episode of Cleveland Clinic’s Cancer Advances podcast, host Dale Shepard, MD, PhD, talked with Zeyad Schwen, MD, about the use of focal therapy to treat patients with localized prostate cancer.

Schwen, who is a urologic oncologist at Cleveland Clinic, covers these topics:

The difference between traditional treatments and focal therapies

Factors that make a patient a good candidate for focal therapy

Focal procedures, including Nanoknife, high-intensity focused ultrasound and cryotherapy

Clinical trials devoted to focal therapies

Zeyad Schwen, MD, a urologic oncologist at Cleveland Clinic, discusses how patient factors and cancer characteristics are key to deciding between focal therapies and whole gland treatment for prostate cancer. 

Dr. Schwen on focal therapies for prostate cancer

In this episode of Speaking of Urology®, 

, discuss precision medicine and the use of biomarker tests in prostate cancer screening and detection. Albala is the chief of urology at Crouse Hospital in Syracuse, New York, and Punnen is an associate professor of urologic oncology and an associate professor and vice chair of research at the Desai Sethi Urology Institute at the University of Miami in Florida.

This discussion originally took place during a live X (formerly Twitter) Spaces event held by Urology Times. In this exclusive interview, Albala and Punnen discussed the significance of advances such as liquid biopsies in prostate cancer, reviewed the current liquid biopsy tests available, and shared their own clinical experiences with the tests in their practice. They also highlighted data on the ExoDx prostate test from studies of clinical utility and validation studies.

Albala and Punnen ended their discussion by highlighting current education gaps surrounding the use of biomarker tests in practice and their predictions for the future of precision medicine.

In this episode, David M. Albala, MD, and Sanoj Punnen, MD, discuss precision medicine and the use of biomarker tests in prostate cancer screening and detection.

Speaking of Urology: Liquid biopsy in prostate cancer 

 (NCT04384770), which compared Magnetic Resonance Imaging-guided stereotactic body radiotherapy with Computed Tomography-guided stereotactic body radiotherapy in localized prostate cancer. Kishan is an associate professor of radiation oncology and urology and the chief of genitourinary oncology for radiation oncology at University of California, Los Angeles. 

Don’t forget to subscribe to Speaking of Urology

Amar Kishan, MD, highlights findings showing that MRI-guided SBRT is superior to CT-guided SBRT in localized prostate cancer.

Dr. Kishan highlights findings from the MIRAGE trial in prostate cancer

® spoke with Dr. Aaron Laviana, who discusses decisional regret in patients with prostate cancer. Laviana is an assistant professor of surgery and perioperative care and a courtesy faculty member of the department of oncology at The University of Texas at Austin Dell Medical School.

“Localized prostate cancer is a very complicated disease space,” says Aaron A. Laviana, MD, MBA.

Dr. Laviana on decisional regret after prostate cancer treatment

®Assistant Editor Janelle Hart spoke with 

. She discusses the findings of a recent 

 study, “Representation in Online Prostate Cancer Content Lacks Racial and Ethnic Diversity: Implications for Black and Latinx Men.” More specifically, she explains how these findings emphasize the need for content creators to focus more on equity, diversity, and inclusion when it comes to online medical literature. Loeb is a professor in the departments of urology and population health at the NYU Grossman School of Medicine in New York City, New York.

“The current landscape of online materials about prostate cancer is generally pretty bleak,” says Stacy Loeb, MD, PhD, MSc.

Study finds lack of Black and Latinx representation in online prostate cancer literature

® Assistant Editor Janelle Hart spoke with 

 She discusses the role that high-intensity focused ultrasound (HIFU) has played among other minimally invasive and robotic technologies to mitigate the side effects and complications of treatment for prostate cancer, compared toe other treatment options. Linehan is an associate professor of urology and urologic oncology at the John Wayne Cancer Institute in Santa Monica, California.

“It's really become the epicenter of all the surgeries that we do in urology,” says Jennifer Linehan, MD.

Emerging HIFU technology shows promise in men with prostate cancer

 He discusses how even though there are stigmas surrounding active surveillance, a lot of research actually suggests that this form of care is preferred in patients with prostate cancer. Therefore, he emphasizes that this treatment method should be counseled accordingly by clinicians. Ehdaie is a urologic surgeon at the Memorial Sloan Kettering Cancer Center, New York City, New York.

“It doesn't need to be surgery or radiation. Setting that stage, really focusing on those conversations, using the appropriate tools that we've grasped from behavioral psychologists that are being used by negotiation specialists, are critical in medicine,” says Behfar Ehdaie, MD, MPH.

Destigmatizing Urology: Dr. Ehdaie discusses active surveillance

. She discusses the benefits of plant-based diets given the promising findings of the prospective study, “Association of plant-based diet index with prostate cancer risk,” published recently in the 

. Loeb is a professor in the departments of urology and population health at the NYU Grossman School of Medicine, New York City, New York.

“We find that consuming more healthy, plant-based foods is associated with a lower risk of aggressive and lethal prostate cancer, and has many other health benefits, too,” says Stacy Loeb, MD, PhD, MSc.

Dr. Loeb on the association between plant-based diets and prostate cancer risk

Here’s a look back at notable news between April and June 2025.

FDA news recap in urology for Q2 2025

Men who live in persistent poverty (PP) census tracts are more likely to be diagnosed with early onset prostate cancer in the distant or metastatic stage compared with those in non-PP census tracts, according to data presented at the 

American Urological Association (AUA) 2025 Annual Meeting

For the study, PP was defined as an area where greater than 20% of people have been below the federal poverty line for 30 years or more. Early onset prostate cancer was defined as a diagnosis in men aged 20 to 59 years.

, highlighted the background and key findings from the study. Davis is a PGY-4 resident at Case Western Reserve/University Hospitals in Cleveland, Ohio.

Laura E. Davis, MD, discusses the link between early onset prostate cancer and persistent poverty. 

Laura Davis, MD, on persistent poverty and early onset prostate cancer 

The study also showed that the higher incidence of distant or metastatic disease was most pronounced in non-Hispanic Black (NHB) men.

The authors reported, “NHB men in PP census tracts had an approximately 46% higher rate of presentation with distant or metastatic prostate cancer than NHB men from census tracts with Non-PP.”

Based on these data, the authors concluded, “Collectively, these data emphasize the need for targeted screening interventions in persistent poverty areas to increase early detection.”

1. Davis LE, Liu F, Dong W, et al. Early onset prostate cancer: a complex interplay between race, poverty, and incidence. 

. 2025;213(5S):e626. doi:10.1097/01.JU.0001109928.76203.bd.08

Videos

The phase 3 ARASTEP trial (NCT05794906) is ongoing to assess the combination of darolutamide (Nubeqa) plus androgen deprivation therapy (ADT) vs ADT alone in the treatment of patients with high-risk biochemical recurrence (BCR) of prostate cancer.

, walked through the design of the study, which was shared during the 

2025 American Society of Clinical Oncology Annual Meeting

“We're trying to understand the way that use of a sustained and intensive hormonal therapy combination can contribute to hopefully prolonging the time until patients have relapse or progression of their disease vs ADT alone,” Morgans noted.

Morgans is a genitourinary medical oncologist and associate professor of medicine at Harvard Medical School as well as the director of the survivorship program at Dana-Farber Cancer Institute in Boston, Massachusetts.

Alicia Morgans, MD, walks through the design of the phase 3 ARASTEP trial of darolutamide plus ADT in biochemical recurrence of prostate cancer.

Alicia Morgans, MD, highlights the phase 3 ARASTEP trial

The randomized study plans to enroll a total of 750 patients across 23 countries.

 BCR is determined by a rising prostate-specific antigen (PSA) level as well as at least 1 positive lesion on PSMA-PET.

According to Morgans, “This is critically important because it sets it apart from other studies that are just looking at PSA relapse in this setting. All patients have to have PSMA-PET positive disease.”

Patients must also have had prior treatment with either radiotherapy or radical prostatectomy with or without radiotherapy, a serum testosterone level of 150 ng/dL or less, and an ECOG performance status of 0 or 1.

Those included in the study will be randomly assigned 1:1 to receive the combination of 600 mg darolutamide plus ADT or ADT alone for 24 months until disease progression, unacceptable toxicity, or study withdrawal. The primary end point is radiographic progression-free survival. Secondary end points include metastasis-free survival, time to castration-resistant prostate cancer, overall survival, and safety.

Primary completion of the study is expected in July 2027.

1. A study to compare darolutamide given with androgen deprivation therapy (ADT) with ADT in men with hormone sensitive prostate cancer and raise of prostate specific antigen (PSA) levels after local therapies (ARASTEP). ClinicalTrials.gov. Last updated June 6, 2025. Accessed June 27, 2025. https://clinicaltrials.gov/study/NCT05794906

2. Morgans A, Niazi T, Shore N, et al. Darolutamide plus androgen deprivation therapy (ADT) in patients with high-risk biochemical recurrence (BCR) of prostate cancer: A phase 3, randomized, double-blind, placebo-controlled study (ARASTEP). 

. 2025;43(5). doi:10.1200/JCO.2025.43.5_suppl.TPS43

The ARASTEP trial is exploring the combination of darolutamide plus ADT vs ADT alone in patients with high-risk biochemical recurrence of prostate cancer.

In a groundbreaking cross-border collaboration, Cleveland Clinic urologists recently completed the world's first remotely performed robot-assisted high-intensity focused ultrasound (HIFU) focal therapy procedure for prostate cancer.

, Ruben Olivares, MD, discussed advancements in medical technology, particularly concerning the treatment of prostate cancer. He highlighted how improved diagnostic tools allow for precise localization of the disease, leading to more targeted treatment options.

Olivares elaborated on HIFU as a recent technological advancement for prostate cancer treatment. He emphasized that this "pinpoint treatment" aims to eradicate the cancer while preserving vital functions like sexual health and urination, which are often negatively affected by traditional treatments.

Ruben Olivares, MD, discussed advancements in medical technology, particularly concerning the treatment of prostate cancer

Ruben Olivares, MD, discusses HIFU and remote prostate cancer care

However, Olivares cautioned that HIFU is not suitable for all patients, particularly those with more aggressive disease, for whom complete gland removal may still be necessary. He stressed the importance of early detection through screening to enable less-invasive options.

A significant challenge with HIFU is its limited availability worldwide and its absence from many training programs. To address this, Olivares envisions expanding access to HIFU through remote procedures, allowing experts from institutions like the Cleveland Clinic, with extensive HIFU experience, to transfer their knowledge and assist in treatments globally. He noted that HIFU technology itself incorporates safety features, and local teams can handle patient positioning and rare complications, allowing remote specialists to largely manage the procedure. This transcontinental approach aims to increase the adoption of minimally invasive options and improve patient access to specialized expertise regardless of geographical location.

1. Cleveland Clinic Abu Dhabi performs world’s first robotic-assisted, transcontinental ultrasound focal therapy procedure for prostate cancer. News release. Cleveland Clinic Abu Dhabi. April 16, 2025. Accessed June 26, 2025. https://www.mediaoffice.abudhabi/en/health/cleveland-clinic-abu-dhabi-performs-worlds-first-robotic-assisted-transcontinental-ultrasound-focal-therapy-procedure-for-prostate-cancer/

Olivares cautioned that HIFU is not suitable for all patients, particularly those with more aggressive disease, for whom complete gland removal may still be necessary. 

The PREVENT trial (NCT04843566) previously showed that transperineal biopsy was associated with fewer infectious complications than transrectal biopsy. However, patients who underwent transperineal reported higher periprocedural pain (0.6 adjusted difference [0-10 scale]; 95% CI, 0.2 to 0.9).

A secondary analysis of the trial, which was presented at the 

2025 American Urological Association Annual Meeting

 in Las Vegas, Nevada, compared the short-term cost-effectiveness of each approach.

, walked through the background and key findings from the analysis.

“The takeaway is that on a population level, on a health care system perspective, it's more cost-effective and safer to do transperineal prostate biopsy,” he said. “I think that helps to add additional texture [or] additional granularity to the data that we have from the original PREVENT trial.”

Huang is a PGY-4 resident at Northwestern University in Chicago, Illinois.

Mitchell Huang, MD, discusses key findings on the cost-effectiveness of transperineal vs transrectal prostate biopsy

Mitchell Huang, MD, on the cost-effectiveness of transperineal vs transrectal prostate biopsy

Specifically, data showed that transperineal prostate biopsy offered greater utility (+0.06 QALY per 1000 patients) and lower cost (-$63,170 per 1000 patients) compared with transrectal prostate biopsy. This finding was durable across the willingness-to-pay thresholds assessed, with 89% to 96% of simulations showing that transperineal biopsy was the more cost-effective option.

Further, the analysis showed that the per-patient cost to prevent a single infectious complication with transperineal biopsy was $3.98.

“The takeaway is that on a population level, on a health care system perspective, it's more cost-effective and safer to do transperineal prostate biopsy,” says Mitchell M. Huang, MD. 

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