Prostate Cancer (Adenocarcinoma)Phase 1/2NCT07862582
RYZ711 Diagnostic Platform Study
A Phase 1/2 study testing RYZ711 and PSMA PET/CT in people with Prostate Cancer (Adenocarcinoma) and Adenocarcinoma of the Prostate, run by RayzeBio, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate, Metastatic Castration-resistant Prostate Cancer (mCRPC)
- What is being tested?
- RYZ711 and PSMA PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who meet all of the following criteria are eligible for inclusion in the study:
- Histologically confirmed adenocarcinoma of the prostate
- ECOG PS ≤ 2
- Planned or scheduled PSMA PET/CT scan
- Cohort 1: Unfavorable intermediate-risk or higher per NCCN 2026 guidelines, with planned RP and extended PLND within 6 weeks of RYZ711 PET/CT
- Cohort 2: Rising PSA after definitive therapy meeting standard BCR criteria (AUA 2026 or Phoenix criteria)
- Cohort 3: mHSPC or mCRPC with documented disease progression; candidate for PSMA-targeted radiopharmaceutical therapy
Who cannot join
- Subjects who meet any of the following criteria will be excluded from the study:
- eGFR < 60 mL/min, QTcF > 470 ms, impaired hepatic function
- Neuroendocrine, sarcomatoid, or spindle cell prostate cancer
- Non-prostate metastatic malignancy
- Cohort 1: Any prior prostate cancer therapy
- Cohort 2: Ongoing or recent ADT (within 3 months prior to Day 1)
- Cohort 3: Prior ¹⁷⁷Lu-PSMA therapy within 6 weeks of PSMA PET/CT
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anthony A Golsorkhi, MD, Study Director, RayzeBio, Inc, MD Study Director contact
About this study
Official title: Phase 1 /2 Multicenter, Basket, Imaging Study Investigating the Safety and Diagnostic Performance of RYZ711 in Men With Prostate Cancer.
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.
- Conditions
- 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
- Being tested
- RYZ711, PSMA PET/CT
- 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
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RYZ711Drug
RYZ711 PET/CT; PSMA PET/CT
PSMA PET/CTDiagnostic test
RYZ711 PET/CT; PSMA PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - RYZ711 | Experimental | High-risk localized prostate cancer planned for RP/PLND Receives: Drug: RYZ711; Diagnostic Test: PSMA PET/CT |
| Cohort 2 - RYZ711 | Experimental | Biochemical recurrence after definitive therapy Receives: Drug: RYZ711; Diagnostic Test: PSMA PET/CT |
| Cohort 3 - RYZ711 | Experimental | Metastatic disease (mHSPC or mCRPC) Receives: Drug: RYZ711; Diagnostic Test: PSMA PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs, SAEs, and Adverse Events of Special Interest (AESIs)
Incidence of AEs, SAEs, and AESIs including changes in vital signs, clinical laboratory evaluations, 12-lead ECG, and other safety findings
Measured: From informed consent up to 3 months post-RYZ711 PET/CT
Concordance Rate of RYZ711 PET/CT Compared with PSMA 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
Measured: Up to 3 months post-RYZ711 PET/CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RayzeBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862582
- Sponsor's protocol ID
- RYZ711-101
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 /2 Multicenter, Basket, Imaging Study Investigating the Safety and Diagnostic Performance of RYZ711 in Men With Prostate Cancer.
- ClinicalTrials.gov ID
- NCT07862582
- Acronym / sponsor ID
- RYZ711-101
- Conditions
- 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
- Keywords
- Prostate Cancer, Adenocarcinoma of the Prostate, ACP3, Acid Phosphatase 3, PAP, RYZ711, PET/CT, Positron Emission Tomography
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- RayzeBio, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - RYZ711 | Experimental | Drug: RYZ711, Diagnostic Test: PSMA PET/CTHigh-risk localized prostate cancer planned for RP/PLND |
| Cohort 2 - RYZ711 | Experimental | Drug: RYZ711, Diagnostic Test: PSMA PET/CTBiochemical recurrence after definitive therapy |
| Cohort 3 - RYZ711 | Experimental | Drug: RYZ711, Diagnostic Test: PSMA PET/CTMetastatic disease (mHSPC or mCRPC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed adenocarcinoma of the prostate
- ECOG PS ≤ 2
- Planned or scheduled PSMA PET/CT scan
- Cohort 1: Unfavorable intermediate-risk or higher per NCCN 2026 guidelines, with planned RP and extended PLND within 6 weeks of RYZ711 PET/CT
- Cohort 2: Rising PSA after definitive therapy meeting standard BCR criteria (AUA 2026 or Phoenix criteria)
Key exclusion criteria (7 listed)
- eGFR < 60 mL/min, QTcF > 470 ms, impaired hepatic function
- Neuroendocrine, sarcomatoid, or spindle cell prostate cancer
- Non-prostate metastatic malignancy
- Cohort 1: Any prior prostate cancer therapy
- Cohort 2: Ongoing or recent ADT (within 3 months prior to Day 1)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RYZ711RYZ711 PET/CT; PSMA PET/CT | Drug | Cohort 1 - RYZ711, Cohort 2 - RYZ711, Cohort 3 - RYZ711 |
| PSMA PET/CTRYZ711 PET/CT; PSMA PET/CT | Diagnostic test | Cohort 1 - RYZ711, Cohort 2 - RYZ711, Cohort 3 - RYZ711 |
Primary outcome
Incidence of AEs, SAEs, and Adverse Events of Special Interest (AESIs)
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anthony A Golsorkhi, MD, Study Director, RayzeBio, Inc, MD Study Director contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RYZ711 and PSMA PET/CT in people with Prostate Cancer (Adenocarcinoma) and Adenocarcinoma of the Prostate, run by RayzeBio, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact RayzeBio Clinical Trials (+1 619 657 0057, clinicaltrials@rayzebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AEs, SAEs, and Adverse Events of Special Interest (AESIs) (time frame: From informed consent up to 3 months post-RYZ711 PET/CT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.