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mCRPCSeptember 2026
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Metastatic Castration Resistant Prostate Cancer — Monthly Compass
Sep 01–30, 2026 • Priority Updates • 3–5 minute read
 
A curated, practice-minded digest of what moved in metastatic castration resistant prostate cancer this month — regulatory signals, clinical development, and the most practice-relevant publications.
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metastatic castration resistant prostate cancer updates
Key Highlights
Key Highlights
  • Key Clinical Development Updates
    • Janux Therapeutics dosed the first patient in its Phase 1 first‑in‑human study of JANX013 (PSMA‑targeted CD28 co‑stimulatory bispecific) in combination with the PSMA‑targeted T‑cell engager JANX007 for mCRPC.
    • China’s NMPA cleared the IND for ICP‑B381, a PSMA/STEAP1 bispecific antibody‑drug conjugate, enabling regional first‑in‑human initiation in mCRPC.
  • Key Conference Updates
    • ASTRO 2026 advanced radiopharmaceutical therapy scale‑up by providing operational frameworks on patient selection, SPECT implementation, reimbursement, and research integration that may influence payer adoption and site credentialing for PSMA‑directed care.
    • CIRSE 2026 highlighted image‑guided in situ intratumoral immunotherapy via SYNC‑T Therapy SV‑102 (single‑needle partial cryolysis plus intratumoral immunotherapy), with the Phase 2 LEGION‑100 trial continuing dose optimization.
  • Emerging Themes & Macro-Trends
    • Convergence on PSMA‑anchored immuno‑oncology—pairing T‑cell redirection with CD28 co‑stimulation and exploring pasritamig (KLK2×CD3) combinations with taxanes, ARPIs, and 177Lu‑vipivotide tetraxetan—targets T‑cell exhaustion and antigen heterogeneity with post‑ARPI, line‑agnostic potential.
    • Alpha/beta PSMA radioligand combinations (225Ac‑J591 plus 177Lu‑PSMA), copper theranostics (67Cu‑SAR‑bisPSMA), and 68Ga‑PSMA PET‑integrated Ra‑223 programs aim to deepen responses, streamline logistics, and refine management of bone‑predominant mCRPC.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • There are no press releases between 2026-09-01 and 2026-09-30 about metastatic castration resistant prostate cancer.
Publications Related to Approved Drugs
Phase 3
apalutamide
Association Between Castration-resistant Prostate Cancer Progression Patterns and Survival Outcomes in Metastatic Castration-sensitive Prostate Cancer: A Post Hoc Analysis of the TITAN Trial. This post hoc analysis of the TITAN trial reveals that apalutamide significantly reduces the incidence of PSA-driven progression to castration-resistant prostate cancer (CRPC) but not radiographic progression. While radiographic CRPC was associated with worse survival in the placebo arm, this prognostic difference was not observed with apalutamide, suggesting it mitigates the poor outcomes of this aggressive progression pattern; patients with baseline visceral metastases may warrant closer imaging as they are more likely to develop radiographic CRPC. ()
New Publications Related to Drugs in Clinical Trial Development
PHASE1, PHASE2
Steroidogenesis inhibitor ODM-209 for metastatic castration-resistant prostate cancer and advanced breast cancer: Results from the first-in-human STESIDES study. The first-in-human STESIDES study reports that ODM-209, a novel oral selective CYP11A1 inhibitor, demonstrated significant activity in heavily pretreated patients with metastatic castration-resistant prostate cancer (mCRPC). A PSA50 response was achieved in 29% of mCRPC patients, with a higher rate of 47% observed in the subgroup with activating AR-LBD mutations, suggesting a promising new therapeutic avenue for this resistant population. The adverse event profile was as expected, with adrenal insufficiency being a key manageable toxicity. ()
Clinical Trials
Clinical Trials Summary
Number of Clinical Trials in metastatic castration resistant prostate cancer updated from 2026-09-01 to 2026-09-30:
Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Total
Enrolling by Invitation-------
Not Yet Recruiting121---4
Recruiting151213112-53
Available-------
Approved for Marketing-------
Active, Not Recruiting449-7-24
Completed-------
Total201823119-81
Phase 1 Clinical Trials within 3 Months of Primary Completion Date:
No phase 1 trials completing within the next three months.
Phase 2 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
AAA617, ARPI: Enzalutamide, ARPI: Abiraterone NCT06894511 ACTIVE_NOT_RECRUITING A Phase II, Open-label, Multi-Center, Randomized Study of Combination of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) and Androgen Receptor Pathway Inhibitor (ARPI) vs. Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in First-line Treatment of Patients With Prostate-Specific Membrane Antigen (PSMA)-Positive Progressive Metastatic Castration Resistant Prostate Cancer (mCRPC) 2026-10-15
Lu-PSMA-617, Cabazitaxel and carboplatin NCT06738303 RECRUITING Carboplatin and Cabazitaxel Versus 177Lu-PSMA-617 in Patients With Aggressive, Metastatic Castrate-resistant Prostate Cancer (CATCH-177) 2026-12
Enzalutamide, Testosterone Undecanoate NCT05081193 ACTIVE_NOT_RECRUITING A Phase II Study Assessing the Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant Prostate Cancer 2026-12-04
Phase 3 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
ARDT, 68Ga-PSMA-11, 177Lu-PSMA-617 NCT04689828 ACTIVE_NOT_RECRUITING PSMAfore: A Phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of Androgen Receptor-Directed Therapy in the Treatment of Taxane Naïve Men With Progressive Metastatic Castrate Resistant Prostate Cancer 2026-09-10
Phase 4 Clinical Trials within 3 Months of Primary Completion Date:
No phase 4 trials completing within the next three months.
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