eligibility_summary
Men ≥18 with mCRPC metastatic adenocarcinoma, ECOG 0–2, life ≥6 mo, castrate T <50, enzalutamide or abiraterone/pred ≥12 wks, taxane given or ineligible/refused, progressing, PSMA+ PET/CT, adequate organs and ≤G2 toxicity, consent/comply. Exclude non-adenocarcinoma, uncontrolled pain, other serious cancers/comorbidities, recent conflicting therapies/radioisotopes, brain/liver mets, seizure/stroke or cord compression ≤6 mo, prior PARP/platinum or PSMA therapy, BRCA1/2/ATM eligible for olaparib.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 randomized, open-label trial in PSMA-positive mCRPC. Interventions: 177Lu‑DOTA‑rosopatamab (TLX591), a radiolabeled anti‑PSMA monoclonal antibody (radioimmunotherapy), given as two IV doses 14 days apart plus best standard of care (SoC) vs SoC alone, a small sub‑study evaluates 177Lu‑DOTA‑TLX591(m17) biodistribution/dosimetry. Mechanism: the antibody binds PSMA (FOLH1) on prostate cancer cells and delivers 177Lu beta radiation to induce DNA damage and tumor cell death. SoC options and mechanisms: enzalutamide (androgen receptor antagonist), abiraterone + prednisone (CYP17A1 inhibitor blocking androgen synthesis), or docetaxel (taxane, microtubule stabilization/mitotic arrest). Targets/pathways: PSMA-expressing prostate tumor cells, androgen-receptor signaling, steroidogenesis, microtubule/mitotic machinery.