RYZ711 Diagnostic Platform Study

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 Exclusion Criteria Subjects who meet any of the following criteria will be excluded from the study: 1. eGFR \< 60 mL/min, QTcF \> 470 ms, impaired hepatic function 2. Neuroendocrine, sarcomatoid, or spindle cell prostate cancer 3. Non-prostate metastatic malignancy 4. Cohort 1: Any prior prostate cancer therapy 5. Cohort 2: Ongoing or recent ADT (within 3 months prior to Day 1) 6. Cohort 3: Prior ¹⁷⁷Lu-PSMA therapy within 6 weeks of PSMA PET/CT