RYZ711 Diagnostic Platform Study

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