Top 5 urologic oncology headlines you missed in July 2025

July 2025 brought a wave of significant advancements in urologic oncology, highlighting the continued innovation transforming the field. Major updates spanned prostate, bladder, and kidney cancers—reflecting progress across the spectrum of care.

In this monthly recap, Urology Times® rounds up the most important regulatory decisions, clinical trial milestones, and practice-changing developments from July 2025.

Scroll down for a look at the top stories that shaped the past month.

1. FDA grants priority review to NDA for TAR-200 in BCG-unresponsive NMIBC

On July 17, 2025, Johnson & Johnson announced that the FDA had granted priority review to the new drug application (NDA) for TAR-200 in BCG-unresponsive high-risk non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

The NDA for TAR-200 is supported by data from cohort 2 of the phase 2b SunRISe-1 trial (NCT04640623), which showed a complete response rate of 82.4%. Additionally, the median duration of response (DOR) was 25.8 months, with 52.9% of responders achieving a DOR of at least 12 months.

2. EMBARK: Significant OS gains seen with enzalutamide plus leuprolide in nmHSPC

New results from the phase 3 EMBARK trial (NCT02319837) showed that treatment with enzalutamide (Xtandi) plus leuprolide acetate significantly improved overall survival (OS) vs placebo plus leuprolide in patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC) and high-risk biochemical recurrence (BCR).

The EMBARK trial previously met its primary endpoint of metastasis-free survival and supported the early use of enzalutamide in men with high-risk BCR who relapsed after prostatectomy or radiation therapy. Full OS data will be presented at an upcoming medical meeting.

3. Aquablation procedures for prostate cancer completed at ambulatory surgery center

On July 23, 2025, PROCEPT BioRobotics announced that 3 patients with localized prostate cancer were successfully treated with Aquablation therapy at an ambulatory surgery center (ASC)—a first for the ongoing WATER IV Prostate Cancer (PCa) trial. The procedures, performed by Rahul Mehan, MD, were completed without complications, and all patients were discharged the same day.

The WATER IV PCa trial (NCT06651632) is a pivotal, randomized study comparing Aquablation therapy vs radical prostatectomy as first-line treatment for patients with grade group 1 to 3 localized prostate cancer. Completion of the trial is expected in July 2027.

Accoridng to Barry Templin, chief technology officer at PROCEPT, early success at an ASC “is indicative of not only a safe prostate resection, but also the potential for a more scalable, cost-effective care model in a rapidly changing market.”

4. FDA grants fast track designation to TRE-515 with 177Lu-PSMA-617 for mCRPC

On July 9, 2025, Trethera Corporation announced that the FDA granted fast track designation to TRE-515 in combination with ¹⁷⁷Lu-PSMA-617 (lutetium Lu 177 vipivotide tetraxetan; Pluvicto) for the treatment of patients with metastatic castration-resistant prostate cancer.

The designation was granted in part based on phase 1 trial results showing early evidence of antitumor activity as well as a favorable safety profile in patients with advanced solid tumors.

5. Metastasis-directed radiotherapy without systemic therapy yields promising outcomes in oligometastatic ccRCC

Metastasis-directed radiotherapy without systemic therapy (MRWS) demonstrated promising efficacy with manageable safety in patients with oligometastatic clear cell renal cell carcinoma, according to data from a phase 2 trial (NCT03575611) presented at the 2025 Kidney Cancer Research Summit in Boston, Massachusetts.

Specifically, at a median follow-up of 36 months (range, 13 to 61), the median progression-free survival was 18 months (95% CI, 16 to 25) and the median systemic therapy-free survival was 34 months (95% CI, 28 to 54). MRWS was also well-tolerated, according to the authors.

"This is an exciting step towards identifying alternative treatments outside of frontline systemic therapy," said lead author Chad Tang, MD, in correspondence with Urology Times®.