Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate, Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), Biochemical Recurrence (BCR), High-Risk Localized Prostate Cancer
Conditions
Keywords
Prostate Cancer, Adenocarcinoma of the Prostate, ACP3, Acid Phosphatase 3, PAP, RYZ711, PET/CT, Positron Emission Tomography, Diagnostic Imaging, Radiopharmaceutical, Radiotracer, PSMA, Prostate-Specific Membrane Antigen, Biochemical Recurrence, Radical Prostatectomy, Pelvic Lymph Node Dissection, PLND, mCRPC, mHSPC, Metastatic Castration-Resistant Prostate Cancer, Metastatic Hormone-Sensitive Prostate Cancer, Targeted Imaging, Prostate-Specific Antigen, PSA, Concordance Rate, Diagnostic Performance, Phase 1, Phase 2, Basket Study, Multicenter Study, Gallium-68 / ⁶⁸Ga, 68Ga-PSMA-11
Brief summary
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.
Interventions
DRUGRYZ711
RYZ711 PET/CT; PSMA PET/CT
DIAGNOSTIC_TESTPSMA PET/CT
RYZ711 PET/CT; PSMA PET/CT
Sponsors
RayzeBio, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This study aims to determine the safety, tolerability, and diagnostic performance of RYZ711 PET/CT in men with histologically confirmed adenocarcinoma of the prostate across 3 cohorts: subjects with newly diagnosed unfavorable intermediate-, high-, or very high-risk prostate cancer planned for Radical Prostatectomy (RP) with extended Pelvic Lymph Node Dissection (PLND) (Cohort 1), subjects with suspected biochemical recurrence (BCR) of prostate cancer following definitive therapy (Cohort 2), and subjects with metastatic disease (mHSPC or mCRPC) who may be candidates for PSMA-targeted radiopharmaceutical therapy (Cohort 3).
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AEs, SAEs, and Adverse Events of Special Interest (AESIs) | From informed consent up to 3 months post-RYZ711 PET/CT | Incidence of AEs, SAEs, and AESIs including changes in vital signs, clinical laboratory evaluations, 12-lead ECG, and other safety findings |
| Concordance Rate of RYZ711 PET/CT Compared with PSMA PET/CT | Up to 3 months post-RYZ711 PET/CT | The concordance rate is defined as the proportion of subjects with per-region correspondence of at least 1 lesion identified on RYZ711 PET/CT and PSMA PET/CT |
Countries
United States
Contacts
CONTACTRayzeBio Clinical Trials
CONTACTAnthony A Golsorkhi, MD, Study Director, RayzeBio, Inc, MD Study Director
Outcome results
None listed