Recruiting
Phase 1
Phase 2

RYZ711

Sponsor:

RayzeBio, Inc.

Code:

NCT07862582

Conditions

Prostate Cancer (Adenocarcinoma)

Adenocarcinoma of the Prostate

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Biochemical Recurrence (BCR)

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RYZ711

PSMA PET/CT

Study Details

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.

Conditions

Prostate Cancer (Adenocarcinoma)

Adenocarcinoma of the Prostate

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Biochemical Recurrence (BCR)

Study ID

NCT07862582

Start date

Oct 5, 2026

Status verified date

Nov, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

116 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Cohort 1 - RYZ711

High-risk localized prostate cancer planned for RP/PLND

experimental: Cohort 2 - RYZ711

Biochemical recurrence after definitive therapy

experimental: Cohort 3 - RYZ711

Metastatic disease (mHSPC or mCRPC)

Interventions

RYZ711

RYZ711 PET/CT; PSMA PET/CT

PSMA PET/CT

RYZ711 PET/CT; PSMA PET/CT

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 ]
  • Concordance Rate of RYZ711 PET/CT Compared with PSMA PET/CT [ Time Frame: Up to 3 months post-RYZ711 PET/CT ]

Central Contacts and Locations

Central contacts

RayzeBio Clinical Trials

+1 619 657 0057clinicaltrials@rayzebio.com

Locations

Research Facility

Recruiting

Omaha, Nebraska, United States, 68130

More Information

Sponsor

RayzeBio, Inc.

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by RayzeBio, Inc. on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.