eligibility_summary
Men ≥18 with localized high-risk prostate cancer: Gleason ≥8 (≥3 cores, ≥8 mm in one), ECOG 0–1, no mets on bone scan/CT/MRI, RP+PLND candidates, no prior PCa therapy (except TURP), adequate labs, MDACC review, consent, contraception. Exclude: immunosuppression/steroids, active infection (controlled HIV OK), major CV/VTE, implants, recent malignancy/surgery, neuro disease/ILD, live vaccine, or transplant.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: REGN5678 and Piflufolastat F 18. REGN5678 is an investigational IV bispecific antibody (co-stimulatory T‑cell engager, anti‑PSMA × CD28). Mechanism: simultaneously binds PSMA on prostate cancer cells and CD28 on T cells to deliver conditional CD28 agonist co‑stimulation, enhancing T‑cell activation, proliferation, cytokine release, and tumor cell killing within PSMA+ lesions. Piflufolastat F 18 (18F‑DCFPyL) is a small‑molecule PSMA‑targeted PET radiotracer used for imaging, not therapy. Targets/pathways: PSMA on prostate tumor epithelial cells, CD28 on T lymphocytes, downstream T‑cell activation/co‑stimulation pathways in the tumor microenvironment. The study assesses safety and pathologic response pre‑prostatectomy in high‑risk localized disease.