eligibility_summary
Inclusion: Men ≥18 with metastatic CRPC adenoCA, ECOG 0–2, life ≥6 mo, T <50 ng/dL, PD (rising PSA ≥2 or RECIST/PCWG3), prior ARPI ≥12 wks with PD (docetaxel in mCSPC ok if ≥6 mo). PSMA‑positive PET (TLR≥2), adequate organs, toxicities ≤G1. Exclusion: non‑adeno (>20% NE), serious comorbidity, recent VTE, allergy, prior PSMA therapy, chemo in mCRPC/nmCRPC, recent systemic tx/RT, radioisotopes <6 mo, other trials <4 wks, brain/liver/lytic bone mets ≥1 cm or low‑PSMA bulky lesions, seizures/stroke <6 mo, prior PARP/platinum.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 ProstACT Global tests 177Lu‑TLX591 (lutetium‑177 rosopatamab tetraxetan) plus standard of care (SOC) vs SOC alone in PSMA‑positive mCRPC post‑ARPI. 177Lu‑TLX591 is a PSMA‑targeted radioimmunotherapy (radioligand/antibody conjugate): a humanized anti‑PSMA monoclonal antibody (rosopatamab) chelated via tetraxetan (DOTA) to 177Lu that binds PSMA on prostate cancer cells and delivers β‑emitting radiation, causing DNA double‑strand breaks and cell death. SOC options/mechanisms: enzalutamide (androgen receptor inhibitor blocking AR signaling), abiraterone (CYP17A1 inhibitor reducing androgen biosynthesis), or docetaxel (taxane stabilizing microtubules, disrupting mitosis and AR trafficking). Targets: PSMA‑expressing prostate tumor cells, AR signaling, androgen synthesis, microtubules/mitotic machinery.