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.
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.
The global radioligand therapy market is projected to grow from $2.6 billion in 2025 to $4.8 billion by 2030 at 13.1% CAGR, driven by FDA label expansions, earlier-line treatment positioning, and substantial private investment in isotope production infrastructure.
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.
DelveInsight releases three separate pipeline reports covering metastatic prostate cancer (80+ companies, 85+ drugs), iPSC-derived NK cells (12+ companies, 15+ drugs), and interstitial lung diseases (120+ companies, 120+ drugs), highlighting recent regulatory approvals, trial launches, and emerging therapies.
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 |
|---|---|---|---|
| NCT07581184 |
A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer |
RECRUITING | PHASE1 |
| NCT07389187 |
Safety and Preliminary Efficacy Evaluation of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) |
NOT_YET_RECRUITING | EARLY_PHASE1 |
| NCT07104643 |
Study of TYK-00540 Combined With Enzalutamide in Patients With Metastatic Castration-resistant Prostate Cancer（mCRPC） |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07103018 |
A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001) |
RECRUITING | PHASE1 |
| NCT07096128 |
A Study of [177Lu] Lu-PSMA-XT Injection in Patients With Metastatic Prostate Cancer |
RECRUITING | PHASE1 |
| NCT07093866 |
Efficacy and Safety of Disitamab Vedotin Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer：a Phase II Study |
RECRUITING | PHASE2 |
| NCT06866548 |
Safety and Efficacy Evaluation of Anti IGF-1R Monoclonal Antibody Combined With Anti-PD-1 Monoclonal Antibody in Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer |
ACTIVE_NOT_RECRUITING | EARLY_PHASE1 |
| NCT06830408 |
Performance of 177Lu-PSMA-I&T for RLT in mCRPC - Prospective Multicenter Swiss Registry Study |
COMPLETED | |
| NCT06659926 |
The Radium-select Study |
RECRUITING | NA |
| NCT06056791 |
Study of INKmune in Patients With mCRPC (CaRe Prostate) |
COMPLETED | PHASE1/PHASE2 |
