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Not yet recruitingPhase 1 / Phase 2

RYZ711 Diagnostic Platform Study

Phase 1 /2 Multicenter, Basket, Imaging Study Investigating the Safety and Diagnostic Performance of RYZ711 in Men With Prostate Cancer.

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests RYZ711 with PET/CT, a scan that makes pictures of the inside of the body. It looks at safety, side effects, and how well the scan detects prostate cancer in men with prostate adenocarcinoma confirmed by a tissue test.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have prostate adenocarcinoma, a type of prostate cancer, confirmed by a tissue test.
  • Can care for yourself and are up and moving for at least half of your waking hours.
  • Have a planned or scheduled PSMA PET/CT scan, which looks for a protein on prostate cancer cells.
  • Group 1: Have cancer rated as unfavorable intermediate-risk or higher under NCCN 2026 guidelines. Plan to have surgery to remove the prostate and nearby lymph nodes within 6 weeks after the RYZ711 scan.
  • Group 2: Have rising PSA, a blood marker, after treatment meant to cure the cancer. The rise must meet standard rules for cancer returning.
  • Group 3: Have prostate cancer that has spread and is getting worse, whether or not it still responds to hormone treatment. Must be able to receive a radioactive drug that targets PSMA.

Who can't join

  • Have a kidney filtering rate below 60 mL/min, a heart rhythm test result called QTcF above 470 milliseconds, or reduced liver function.
  • Have neuroendocrine, sarcomatoid, or spindle cell prostate cancer. These are specific types of prostate cancer.
  • Have cancer from somewhere other than the prostate that has spread.
  • Group 1: Have had any prostate cancer treatment.
  • Group 2: Are receiving hormone-lowering treatment called ADT, or received it within 3 months before Day 1.
  • Group 3: Received lutetium-177 PSMA treatment, a radioactive drug treatment, within 6 weeks before the PSMA PET/CT scan.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NE