RayzeBio, Inc.
This is a Phase 1/2 multicenter, multi-cohort imaging study to evaluate the safety, tolerability, and diagnostic performance of RYZ711 positron emission tomography/computed tomography (PET/CT) in men with histologically confirmed adenocarcinoma of the prostate.
Inclusion Criteria Subjects who meet all of the following criteria are eligible for inclusion in the study: 1. Histologically confirmed adenocarcinoma of the prostate 2. ECOG PS ≤ 2 3. Planned or scheduled PSMA PET/CT scan 4. Cohort 1: Unfavorable intermediate-risk or higher per NCCN 2026 guidelines, with planned RP and extended PLND within 6 weeks of RYZ711 PET/CT 5. Cohort 2: Rising PSA after definitive therapy meeting standard BCR criteria (AUA 2026 or Phoenix criteria) 6. Cohort 3: mHSPC or mCRPC with documented disease progression; candidate for PSMA-targeted radiopharmaceutical therapy…
RYZ711 PET/CT; PSMA PET/CT
RYZ711 PET/CT; PSMA PET/CT
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