10 urology trials in progress to be highlighted at AUA 2025

This year's meeting will highlight several trials in prostate cancer, bladder cancer, and more.

The 2025 American Urological Association Annual Meeting, set to begin later this week in Las Vegas, Nevada, will feature multiple presentations on phase 3 trials that are currently underway in a variety of disease states, including bladder cancer and prostate cancer. As part of our coverage of the meeting, here are several notable trials in progress attendees can expect to hear about this year.

SunRISe-5: A phase 3, randomized, open-label study of TAR-200 compared with intravesical chemotherapy after bacillus Calmette-Guérin in recurrent high-risk non–muscle-invasive bladder cancer

Presentation time: Monday, April 28, 2025 9:40 AM to 9:48 AM PST

Description: Sima P. Porten, MD, MPH, will discuss the phase 3 SunRISe-5 trial (NCT06211764) evaluating TAR-200 vs intravesical chemotherapy in patients with recurrent high-risk non–muscle-invasive bladder cancer after BCG treatment. The primary outcome is disease-free survival, with recurrence-free survival, time to next intervention, time to disease worsening, time to progression, and overall survival among the secondary outcomes.¹

MoonRISe-1: Phase 3 study of TAR-210, an intravesical erdafitinib releasing system, versus intravesical chemotherapy in patients with FGFR-altered intermediate-risk non–muscle-invasive bladder cancer

Presentation time: Monday, April 28, 2025 9:08 AM to 9:16 AM PST

Description: Roger Li, MD, will provide an update on the phase 3 MoonRISe-1 study of TAR-210. In a previous interview with Urology Times®, Li described the trial: “In the MoonRISe-1 study, we're studying the efficacy of TAR-210 to prevent recurrence within the bladder by inserting the TAR-210 in the bladder every 3 months for up to 1 year, compared to intravesical chemotherapy, either mitomycin C, or gemcitabine, using an induction course of 4 to 6 weekly induction, followed by a 6 to 12 monthly maintenance therapy. The primary end point is disease-free survival, independent of the tumor stage or the grade.”

Phase 3 study of TAR-210 intravesical erdafitinib releasing system vs intravesical chemotherapy in patients with Bacillus Calmette-Guérin–treated high-risk non–muscle-invasive bladder cancer with susceptible FGFR alterations

Presentation time: Monday, April 28, 2025 9:56 AM to 10:04 AM PST

Description: Neal D. Shore, MD, FACS, will present on this phase 3 study of TAR-210.

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)

Presentation time: Monday, April 28, 2025 2:44 PM to 2:52 PM PST

Description: Neal D. Shore, MD, will discuss the phase 3 ARASTEP trial (NCT05794906). Patients are randomly assigned to receive darolutamide (Nubeqa) plus androgen deprivation therapy (ADT) or placebo plus ADT. The primary outcome is radiological progression-free survival, and secondary outcomes include metastasis-free survival by conventional imaging assessed by BICR, time to castration-resistant prostate cancer, time to initiation of first subsequent systemic antineoplastic therapy, and overall survival.²

PSMA-delay castration (DC): an open-label, multicenter, randomized phase 3 study of [177Lu]Lu-PSMA-617 versus observation in patients with metachronous PSMA-positive oligometastatic prostate cancer (OMPC)

Presentation time: Monday, April 28, 2025 2:52 PM to 3:00 PM PST

Description: Neal D. Shore, MD, FACS, will present on this phase 3 study. Last month, the FDA approved a label expansion to move ¹⁷⁷Lu-PSMA-617 (Pluvicto) into the pre-chemotherapy setting for patients with metastatic castration-resistant prostate cancer (mCRPC).³

The effect of vesicopexy on urinary continence and quality of life following robotic-assisted radical prostatectomy: A phase III randomized clinical trial

Presentation time: Monday, April 28, 2025 2:20 PM to 2:28 PM PST

Description: Hooman Djaladat, MD, will share details on a phase 3 trial (NCT04981834) of robot-assisted radical prostatectomy (RARP) with or without vesicopexy in patients with prostate cancer.⁴ The primary outcome measure is the effect of vesicopexy on 3-month urinary continence rate. Secondary outcomes also include comparisons of quality of life, sexual function, and post-operative complications at 3 months.

ProstACT GLOBAL: A phase 3 study of 177Lu-rosptamab plus standard of care vs. standard of care alone in patients with metastatic castration-resistant prostate cancer

Presentation time: Monday, April 28, 2025 1:00 PM to 1:08 PM PST

Description: Scott T. Tagawa, MD, MS, FACP, FASCO, will outline the design of the phase 3 ProstACT GLOBAL trial (NCT06520345), which is assessing the safety and efficacy of second-line ¹⁷⁷Lu-rosptamab plus standard of care (SOC) vs SOC alone in patients with mCRPC who have progressed on an androgen receptor pathway inhibitor. The study will be completed in 3 phases: safety and dosimetry lead-in, randomized treatment expansion, and long-term follow-up.⁵ The primary outcome measure is radiographic progression-free survival.

Telix Pharmaceuticals announced the dosing of the first patient in the trial in November 2023.⁶ In total, the study plans to enroll approximately 430 patients.

WATER IV prostate cancer: A randomized phase III study of Aquablation versus radical prostatectomy for the treatment of localized prostate cancer

Presentation time: Monday, April 28, 2025 1:08 PM to 1:16 PM PST

Description: Inderbir S. Gill, MD, will present on the prospective, multicenter WATER IV trial (NCT06651632), which is comparing the safety and efficacy of Aquablation vs radical prostatectomy for the treatment of patients with localized prostate cancer.⁷ In total, the study plans to enroll approximately 280 patients, and participants in the study will be followed for up to 10 years. The primary outcome measures are urinary incontinence and erectile function at 6 months following the procedure.

SWOG S1931 (PROBE): Phase III randomized trial of immune checkpoint inhibitor (ICI) combination regimen with or without cytoreductive nephrectomy (CN) in advanced renal cancer

Presentation time: Monday, April 28, 2025 1:16 PM to 1:24 PM PST

Description: Details on the PROBE trial (NCT04510597) will be presented by Hyung L. Kim, MD. Overall, the trial is assessing whether the addition of cytoreductive nephrectomy to a standard of care immunotherapy-based drug combination will improve overall survival vs the drug combination alone in patients with treatment-naïve metastatic renal cell carcinoma.⁸

Participants will be assigned to 1 of 3 treatment regimens: nivolumab (Opdivo) plus ipilimumab (Yervoy), pembrolizumab (Keytruda) and axitinib (Inlyta), or avelumab (Bavencio) and axitinib. Participants will then be randomly assigned to continuation of treatment with or without the addition of radical or partial nephrectomy.

PIVOT-006- A phase 3, randomized study of adjuvant intravesical cretostimogene grenadenorepvec versus surveillance for the treatment of intermediate-risk non-muscle invasive bladder cancer

Presentation time: Monday, April 28, 2025 10:20 AM to 10:28 AM PST

Description: Max Kates, MD, will present on the PIVOT-006 trial, which is evaluating adjuvant cretostimogene grenadenorepvec vs surveillance after TURBT in patients with intermediate-risk non–muscle invasive bladder cancer.⁹ In total, the open-label trial plans to enroll 364 patients across 88 clinical trials sites in the US and Canada.

In addition to PIVOT-006, the trial platform for cretostimogene grenadenorepvec includes the BOND-003 trial (NCT04452591) and the CORE-008 trial (NCT06567743), both of which will also be spotlighted at this year’s meeting.

REFERENCES

1. A study of TAR-200 versus intravesical chemotherapy in participants with recurrent high-risk non-muscle-invasive bladder cancer (HR-NMIBC) after Bacillus Calmette-Guérin (BCG) (SunRISe-5). ClinicalTrials.gov. Last updated April 3, 2025. Accessed April 22, 2025. https://clinicaltrials.gov/study/NCT06211764

2. 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 April 6, 2025. Accessed April 22, 2025. https://clinicaltrials.gov/study/NCT05794906

3. FDA approves Novartis radioligand therapy Pluvicto for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer. News release. Novartis Pharma AG. March 28, 2025. Acessed April 22, 2025. https://www.novartis.com/news/media-releases/fda-approves-novartis-radioligand-therapy-pluvicto-earlier-use-chemotherapy-psma-positive-metastatic-castration-resistant-prostate-cancer

4. Robot-assisted radical prostatectomy with or without vesicopexy in patients with prostate cancer. ClinicalTrials.gov. Last updated May 24, 2024. Accessed April 22, 2025. https://clinicaltrials.gov/study/NCT04981834

5. The study of 177Lu-TLX591 plus SOC versus SOC alone in patients with mCRPC (ProstACT Global). ClinicalTrials.gov. February 28, 2025. Accessed April 22, 2025. https://clinicaltrials.gov/study/NCT06520345

6. First patient dosed in phase III ProstACT GLOBAL study of antibody-based prostate cancer therapy candidate TLX591. News release. Telix Pharmaceuticals Limited. November 12, 2023. Accessed April 22, 2025. https://www.prnewswire.com/news-releases/first-patient-dosed-in-phase-iii-prostact-global-study-of-antibody-based-prostate-cancer-therapy-candidate-tlx591-301985377.html

7. WATER IV Prostate Cancer (WATER IV PCa). ClinicalTrials.gov. Last updated April 3, 2025. Accessed April 22, 2025. https://clinicaltrials.gov/study/NCT06651632

8. Comparing the outcome of immunotherapy-based drug combination therapy with or without surgery to remove the kidney in metastatic kidney cancer, the PROBE trial (PROBE). ClinicalTrials.gov. Last updated August 16, 2024. Accessed April 22, 2025. https://clinicaltrials.gov/study/NCT04510597

9. A study of adjuvant cretostimogene grenadenorepvec for treatment of intermediate risk NMIBC following TURBT. ClinicalTrials.gov. Last updated April 17, 2025. Accessed April 22, 2025. https://clinicaltrials.gov/study/NCT06111235