Prostate Cancer Experts Preview Trials to Watch at ASCO GU 2026

As anticipation builds for the 2026 American Society of Clinical Oncology Genitourinary (GU) Cancers Symposium, OncLive asked leading specialists to share the prostate cancer topics and data they are most eager to follow at this year’s meeting.

We gathered exclusive insights from:

• Axel Merseburger, MD, PhD, professor of urology and head of the Department of Urology at University Hospital Schleswig-Holstein in Lübeck, Germany
• Guru Sonpavde, MD, medical director for GU Oncology, assistant director of the Clinical Research Unit, and the Christopher K. Glanz Chair for Bladder Cancer Research at AdventHealth Cancer Institute in Orlando, Florida

Prostate cancer specialists are closely watching a series of late-stage and maturing trials that may further refine treatment intensification strategies across localized, hormone-sensitive, and castration-resistant disease settings. Among the most closely anticipated readouts are the first results from the randomized phase 3 PEACE-2 trial (NCT01952223), which is evaluating androgen deprivation therapy (ADT) and radiotherapy with or without cabazitaxel in patients with very–high-risk localized prostate cancer, with the goal of determining whether early systemic intensification can improve long-term outcomes.¹

Additional attention is focused on studies leveraging molecular selection and advanced imaging to guide therapy earlier in the disease course and their associations with quality of life. The phase 3 PSMAddition trial (NCT04720157) assessed the addition of lutetium Lu 177 vipivotide tetraxetan (Pluvicto) to standard-of-care therapy in metastatic hormone-sensitive prostate cancer (mHSPC), using prostate-specific membrane antigen (PSMA)–PET imaging to select patients.² In parallel, from the phase 3 CAPItello-281 trial (NCT04493853), investigators will present patient-reported outcomes and tolerability data for capivasertib (Truqap) plus abiraterone acetate (Zytiga) vs placebo plus abiraterone in patients with PTEN-deficient mHSPC, underscoring the growing emphasis on biomarker-driven approaches and quality-of-life considerations alongside efficacy.³

In more advanced disease, final overall survival (OS) data from the phase 3 EORTC 1333/PEACE-3 trial (NCT02194842) are expected to provide important clarity on the role of combination radiopharmaceutical and androgen receptor–targeted therapy. PEACE-3 evaluated enzalutamide (Xtandi) with or without radium Ra 223 dichloride (radium-223; Xofigo) as first-line treatment for patients with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases, building on earlier findings demonstrating significant improvements in radiographic progression-free survival and OS. Collectively, these data are poised to inform how intensification, molecular selection, and novel combinations may be optimally integrated into prostate cancer management across disease states.

Androgen deprivation therapy and radiotherapy with or without cabazitaxel in very high-risk localized prostate cancer: First results of the PEACE-2 randomized phase 3 trial

Merseburger: Across prostate cancer, I am particularly looking forward to data from studies such as PEACE-2 and PSMAddition, which continue to define how intensification strategies incorporating novel androgen receptor pathway inhibitors and advanced imaging with PSMA-PET can reshape risk stratification and up-front management [in the metastatic hormone-sensitive and other high-risk settings].

Patient-reported outcomes and tolerability of capivasertib plus abiraterone vs placebo plus abi in patients (pts) with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC): CAPItello-281

Merseburger: Trials like CAPItello and [the phase 1] PAnTHA trial [NCT06217822] highlight how molecularly driven and radioligand strategies are moving earlier in the disease course, potentially shifting the treatment paradigm for selected high-risk and biomarker-defined populations.

Final overall survival results from the EORTC 1333/PEACE-3 trial: Enzalutamide with or without radium-223 in metastatic castration-resistant prostate cancer

Sonpavde: PEACE-3 has already demonstrated that combining enzalutamide with radium-223 as first-line therapy for metastatic castration-resistant prostate cancer with bone metastases significantly improves radiographic progression-free survival (rPFS) and overall survival. Now, the final OS results are being presented.

References

1. A phase III trial of cabazitaxel and pelvic radiotherapy in localized prostate cancer and high-risk features of relapse (PEACE2). ClinicalTrials.gov. Updated July 30, 2025. Accessed February 11, 2026. https://clinicaltrials.gov/study/NCT01952223
2. An international prospective, open-label, randomized phase III study comparing 177Lu-PSMA-617 in combination with standard of care (SoC), versus SoC alone, in adult male patients with metastatic hormone-sensitive prostate cancer (mHSPC) (PSMAddition). ClinicalTrials.gov. Updated February 10, 2026. Accessed February 11, 2026. https://clinicaltrials.gov/study/NCT04720157
3. Fizazi K, Clarke NW, De Santis M, et al. Capivasertib plus abiraterone in PTEN-deficient metastatic hormone-sensitive prostate cancer: CAPItello-281 phase III study. Ann Oncol. 2026;37(1):53-68. doi:10.1016/j.annonc.2025.10.004
4. Gillessen S, Choudhury A, Saad F, et al. A randomized multicenter open label phase III trial comparing enzalutamide vs a combination of Radium-223 (Ra223) and enzalutamide in asymptomatic or mildly symptomatic patients with bone metastatic castration-resistant prostate cancer (mCRPC): first results of EORTC-GUCG 1333/PEACE-3. Ann Oncol. 2024;35(suppl 2):S1254. doi:10.1016/j.annonc.2024.08.2307