NCT07862582 RYZ711 Diagnostic Platform Study
| NCT ID | NCT07862582 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | RayzeBio, Inc. |
| Condition | Prostate Cancer (Adenocarcinoma) |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2026-10-05 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 116 participants in total. It began in 2026-10-05 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07862582 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer (Adenocarcinoma). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07862582 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07862582 currently recruiting?
Yes, NCT07862582 is actively recruiting participants. Contact the research team at clinicaltrials@rayzebio.com for enrollment information.
Where is the NCT07862582 trial being conducted?
This trial is being conducted at Omaha, United States.
Who is sponsoring the NCT07862582 clinical trial?
NCT07862582 is sponsored by RayzeBio, Inc.. The trial plans to enroll 116 participants.
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