Top 10 Urology Times prostate cancer articles of 2025

FDA news and prostate-specific membrane antigen (PSMA)-related content were the key themes of Urology Times’ top prostate cancer from 2025. Other highly read content included news about the Cleveland Clinic performing the first remote robot-assisted high-intensity focused ultrasound (HIFU) as well as data pointing to the potential role of exercise for improving erectile function in men with prostate cancer.

Baseline 68Ga-PSMA-11 PET/CT parameters can predict response to 177Lu-PSMA-617

In this interview, Phillip H. Kuo, MD, PhD, FACR, shares key findings and takeaways from the study, “Quantitative ⁶⁸Ga-PSMA-11 PET and clinical outcomes in metastatic castration-resistant prostate cancer following ¹⁷⁷Lu-PSMA-617 (VISION trial),”¹ for which he served as the lead author. Kuo is a professor of radiology, section chief of nuclear medicine, and director of theranostics for the department of radiology at City of Hope National Medical Center in Duarte, California.

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

The investigational PET imaging agent ⁶⁴Cu-SAR-bisPSMA was effective in detecting prostate cancer lesions in patients with biochemical recurrence and negative or equivocal standard of care (SOC) imaging, according to findings from the phase 1/2 COBRA trial (NCT05249127).² The data were presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California.

Urologists perform first remote robot-assisted HIFU for prostate cancer

Urologists from Cleveland Clinic have collaborated across borders to perform the world’s first remotely conducted robot–assisted high-intensity focused ultrasound (HIFU) focal therapy procedure for prostate cancer.³ Remote operation for the HIFU procedure was conducted by Ruben Olivares, MD, of Cleveland Clinic’s main campus, who was more than 7000 miles away from the procedure that was performed at Cleveland Clinic Abu Dhabi.

FDA approves PET imaging product Gozellix for prostate cancer

On March 20, 2025, the FDA approved Gozellix (TLX007-CDx), a proprietary cold kit for the preparation of gallium-68 (68Ga) gozetotide injection, Telix Pharmaceuticals announced in a news release.⁴ Specifically, Gozellix—after radiolabeling with 68Ga—is indicated in patients with prostate cancer who have suspected metastases and are candidates for initial definitive therapy and patients who have suspected recurrence of prostate cancer based on an elevated serum prostate-specific antigen level.

FDA grants de novo authorization to ArteraAI Prostate

The FDA has granted de novo authorization to ArteraAI Prostate, an artificial intelligence (AI)-powered risk stratification tool for patients with non-metastatic prostate cancer, Artera announced in a news release.⁵ The tool, which uses multimodal artificial intelligence technology, is now the first and only AI-powered tool to be authorized to prognosticate long-term outcomes in patients with localized prostate cancer.

FDA approves expanded label for 177Lu-PSMA-617 in mCRPC

The FDA has approved an expanded indication for ¹⁷⁷Lu-PSMA-617 (lutetium Lu 177 vipivotide tetraxetan; Pluvicto) to include use in patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with an androgen receptor pathway inhibitor therapy and are considered appropriate to delay taxane-based chemotherapy.⁶

Exercise may improve erectile function in men with prostate cancer

A recent study published in JAMA Network Open found that 6 months of supervised resistance and aerobic exercise improved erectile function, compared with regular care, in men with prostate cancer.⁷ According to the authors, these data support the use of exercise as a potential rehabilitation measure in these patients.

FDA Advisory Committee unanimously votes against talazoparib plus enzalutamide for mCRPC

The FDA’s Oncologic Drugs Advisory Committee) voted in a unanimous 0-8 decision that the TALAPRO-2 data on talazoparib (Talzenna) in combination with enzalutamide (Xtandi) is not sufficient to conclude a favorable benefit-risk profile in adult patients with metastatic castration-resistant prostate cancer unselected for homologous recombination repair (HRR) gene alterations.⁸ In their decision, the committee expressed concerns over a trial design that did not specifically stratify for patients without HRR gene mutations. They also cited concerns over the toxicity of this regimen in this population.

FDA grants fast track designation to pasritamig for mCRPC

The FDA has granted fast track designation to pasritamig (JNJ-78278343), an investigational first-in-class bispecific T-cell-engaging antibody targeting human kallikrein 2 for patients with metastatic castration-resistant prostate cancer, Johnson & Johnson announced in a news release.⁹

Baseline 68Ga-PSMA-11 PET/CT parameters can predict response to 177Lu-PSMA-617

In this interview, Phillip H. Kuo, MD, PhD, FACR, shares key findings and takeaways from the study, “Quantitative ⁶⁸Ga-PSMA-11 PET and clinical outcomes in metastatic castration-resistant prostate cancer following ¹⁷⁷Lu-PSMA-617 (VISION trial),”¹⁰ for which he served as the lead author.

REFERENCES

1. Kuo PH, Morris MJ, Hesterman J, et al. Quantitative 68Ga-PSMA-11 PET and clinical outcomes in metastatic castration-resistant prostate cancer following 177Lu-PSMA-617 (VISION trial). Radiology. 2024;312(2):e233460. doi:10.1148/radiol.233460

2. Nordquist L, Lengyelova E, Saltzstein D, et al. COBRA: Assessment of the efficacy of 64Cu-SAR-bisPSMA using histopathology as reference standard in patients with biochemical recurrence of prostate cancer following definitive therapy. J Clin Oncol. 2025;43 (suppl 5). Abstract 44. doi:10.1200/JCO.2025.43.5_suppl.44

3. 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 December 12, 2025. https://www.mediaoffice.abudhabi/en/health/cleveland-clinic-abu-dhabi-performs-worlds-first-robotic-assisted-transcontinental-ultrasound-focal-therapy-procedure-for-prostate-cancer/

4. FDA approves new prostate cancer imaging agent Gozellix. News release. Telix Pharmaceuticals. March 20, 2025. Accessed December 12, 2025. https://telixpharma.com/news-views/fda-approves-new-prostate-cancer-imaging-agent-gozellix/

5. Artera receives U.S. FDA De Novo Marketing Authorization for AI-digital pathology software revolutionizing prostate cancer care. News release. Artera. August 13, 2025. Accessed December 12, 2025. https://www.businesswire.com/news/home/20250813857439/en/Artera-Receives-U.S.-FDA-De-Novo-Marketing-Authorization-for-AI-Digital-Pathology-Software-Revolutionizing-Prostate-Cancer-Care

6. 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. Accessed December 12, 2025. https://www.novartis.com/news/media-releases/fda-approves-novartis-radioligand-therapy-pluvicto-earlier-use-chemotherapy-psma-positive-metastatic-castration-resistant-prostate-cancer

7. Galvão DA, Newton RU, Taaffe DR, et al. Exercise and psychosexual education to improve sexual function in men with prostate cancer: a randomized clinical trial. JAMA Netw Open. 2025;8(3):e250413. doi:10.1001/jamanetworkopen.2025.0413

8. May 20-21, 2025 Meeting of the Oncologic Drugs Advisory Committee. US Food & Drug Administration. Accessed May 21, 2025. https://www.fda.gov/media/186530/download

9. Johnson & Johnson enters new era in solid tumors at ESMO 2025 with promising data across multiple cancer types. News release. Johnson & Johnson. October 15, 2025. Accessed December 12, 2025. https://innovativemedicine.jnj.com/us/news-center/oncology/johnson-johnson-enters-new-era-in-solid-tumors-at-esmo-2025-with-promising-data-across-multiple-cancer-types?sf229310720=1&sf229378866=1

10. Kuo PH, Morris MJ, Hesterman J, et al. Quantitative ⁶⁸Ga-PSMA-11 PET and clinical outcomes in metastatic castration-resistant prostate cancer following ¹⁷⁷Lu-PSMA-617 (VISION trial). Radiology. 2024;312(2):e233460. doi:10.1148/radiol.233460