Also known as: Xtandi
Enzalutamide is an oral nonsteroidal antiandrogen marketed as Xtandi for castration-resistant and castration-sensitive prostate cancer settings in combination with castration. It is a second-generation androgen receptor pathway inhibitor with U.S. and EU prescription-only status. The therapy was introduced for prostate cancer in 2012.
A post hoc STAMPEDE analysis found lower on-treatment PSA levels were strongly associated with improved long-term survival in advanced prostate cancer, but disease burden still affected outcomes.
Telix said Part 1 of the ProstACT Global Phase 3 study met its primary objectives for TLX591-Tx in mCRPC. The company reported acceptable safety, no new safety signals and progression plans for Part 2.
ORIC selected rinzimetostat 400 mg plus darolutamide for the Himalayas-1 Phase 3 trial in post-abiraterone mCRPC, expected to start in 1H 2026. The company reported early efficacy and safety data and said cash runway extends into 2H 2028.
PARP inhibitors remain strongest in BRCA1/2-altered tumors as use beyond that group has been uneven. In June 2025, the FDA narrowed Zejula’s first-line ovarian maintenance indication to HRD-positive tumors only.
Vir Biotechnology has dosed the first patient in a Phase I VIR-5500 expansion cohort for metastatic prostate cancer. The trial is evaluating VIR-5500 as monotherapy and in combination settings across mCRPC and mHSPC.
New research shows genomic profiling can detect aggressive prostate cancer not identified at biopsy, while a separate study reveals PTGES3 as a potential therapeutic target for treatment-resistant disease.
Pfizer reported positive Phase 3 trial results for BRAFTOVI combination therapy in metastatic colorectal cancer and received FDA Priority Review for HYMPAVZI expansion to hemophilia patients including children.
The 2026 ASCO GU Symposium featured significant trial results in renal cell carcinoma, urothelial carcinoma, and prostate cancer, including data from LITESPARK-022, KEYNOTE-B15, SunRISE-2, and PEACE-3 studies.
Vir Biotechnology reported Q4 EPS of ($0.31), beating estimates by $0.23, with revenue of $64.07 million. The company announced a global strategic collaboration with Astellas for VIR-5500 and reported $781.6 million in cash and investments.
Vir Biotechnology announced a global strategic collaboration with Astellas for VIR-5500, a PSMA-targeted dual-masked T-cell engager for prostate cancer, and reported $781.6 million in cash and investments as of December 31, 2025.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07592910 |
A Study of Mevrometostat With Enzalutamide in People With Prostate Cancer Who Have Previously Received Androgen Receptor Pathway Inhibitor Therapy |
NOT_YET_RECRUITING | PHASE2 |
| NCT07570979 |
A Study to Investigate the Safety and Tolerability of Oral INR731 Single Agent or in Combination With Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Metastatic Prostate Cancer |
RECRUITING | PHASE1 |
| NCT07428642 |
PSMA PET/CT-Based Multimodal Model for Predicting Response to First-Line Therapy in mHSPC. |
COMPLETED | |
| NCT07406282 |
A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics |
RECRUITING | |
| NCT07287150 |
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer |
RECRUITING | PHASE2 |
| NCT07277270 |
A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors |
RECRUITING | PHASE1 |
| NCT07226986 |
A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC |
RECRUITING | PHASE1/PHASE2 |
| NCT07198633 |
A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07104643 |
Study of TYK-00540 Combined With Enzalutamide in Patients With Metastatic Castration-resistant Prostate Cancer（mCRPC） |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07104110 |
Study of QLH12016 in Combination With Novel Hormonal Agent in Subjects With Advanced Prostate Cancer |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
