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.
PSMA-PET imaging leads to earlier use of advanced therapies like ARPIs in prostate cancer patients compared to bone scans. Real-world data on 177Lu-PSMA-617 shows comparable efficacy to the VISION trial in mCRPC patients.
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.
Proteolysis-targeting chimeras (PROTACs) are advancing from experimental to clinical-stage cancer therapies, with first candidates entering Phase III trials. The technology degrades target proteins rather than blocking them, offering new options for previously undruggable targets.
Pluvicto (lutetium-177 vipivotide tetraxetan) received MHRA authorization for earlier use in metastatic castration-resistant prostate cancer, while pooled trial data demonstrates improved progression-free survival without increased toxicity.
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.
Another participant with metastatic castration-resistant prostate cancer achieved undetectable PSA and negative PSMA PET after treatment with 67Cu-SAR-bisPSMA in the SECuRE trial. This marks the fifth patient to achieve undetectable disease by radiographic assessment in Clarity Pharmaceuticals' program.
Multiple pharmaceutical companies have initiated clinical trials for metastatic castration-resistant prostate cancer in February 2026, with over 180 companies developing 200+ pipeline therapies. Studies include combination therapies and novel drug candidates targeting advanced disease.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07553988 |
A Comparative Dose-finding Study of RS-113 in Patients With Metastatic Castration-resistant Prostate Cancer |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT07545811 |
Study of JANX014 in Subjects With Metastatic Castration-Resistant Prostate Cancer |
RECRUITING | PHASE1 |
| NCT07476001 |
Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC |
RECRUITING | PHASE2 |
| NCT07423117 |
A Study of ITC-6146RO in Patients With Advanced or Metastatic Cancer Who Have Failed Standard Therapy |
NOT_YET_RECRUITING | PHASE1 |
| NCT07414940 |
ACTinium in Castrate-RESistant Prostate Cancer After LUTEtium |
RECRUITING | PHASE1/PHASE2 |
| NCT07365995 |
A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer |
RECRUITING | PHASE3 |
| NCT07344311 |
A Phase I Trial of A-CAR032 in Participants With mCRPC |
RECRUITING | PHASE1 |
| NCT07339267 |
A Study to Evaluate the Safety and Drug Levels of ASP5541 in Chinese Participants With Prostate Cancer |
RECRUITING | PHASE1 |
| NCT07288359 |
Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors |
RECRUITING | PHASE1/PHASE2 |
| NCT07287150 |
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer |
RECRUITING | PHASE2 |
