rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance

NCT ID: NCT05852041

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-07
• Study Completion Date: 2035-06-07

Brief Summary

This clinical trial evaluates whether positron emission tomography-magnetic resonance imaging (PET-MRI) using the radioactive drug radiohybrid prostate-specific membrane antigen (rhPSMA)-7.3 may help in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer who are candidates for active surveillance. A PET scan is a test that uses a radioactive drug and a computer to create images of how organs and tissues in the body are functioning. The radioactive drug used in this study, rhPSMA-7.3, attaches to the abnormal cells in the body at a different rate than normal cells which allows the scanner to create a detailed picture of how the body is working. An MRI scan uses strong magnets and computers to create detailed images of the soft tissue in your body. A multiparametric (mp)MRI is a type of MRI scan that creates a more detailed picture of the prostate gland. Using rhPSMA-73 with PET-MRI and mpMRI may be more effective in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer.

Detailed Description

PRIMARY OBJECTIVE:

I. Measure the rate of rhPSMA-7.3-PET-MRI identified Gleason Grade Group (GG) 3-5 disease on pathology or locally advanced disease. A threshold rate of 15% detection will be considered clinically significant.

SEONDARY OBJECTIVE:

I. Assessment of safety.

EXPLORATORY OBJECTIVES:

I. Determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for rhPSMA-PET-MRI to detect prostate cancer in the prostate stratified by Gleason Grade Groups.

II. Correlate PET MRI findings with surgical specimens for those men who undergo surgical treatment (including assessment of pathological stage).

III. Define whether gene expression of PSMA (FOLH1) as defined on the Decipher messenger ribonucleic acid (mRNA) expression platform relates to signal intensity on PSMA scan.

IV. Determine whether Decipher genomic classifier scores, luminal / basal scores or androgen receptor activity scores relate to signal intensity on PSMA scans.

OUTLINE:

Patients receive rhPSMA-7.3 intravenously (IV) then undergo PET-MRI and mpMRI of the prostate on study. Patients also undergo Decipher test at screening and MRI-PET prostate biopsy or radical prostatectomy within 90 days per standard of care.

Conditions

Prostate Adenocarcinoma; Stage I Prostate Cancer AJCC v8; Stage IIA Prostate Cancer AJCC v8; Stage IIB Prostate Cancer AJCC v8

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Treatment (rhPSMA, PET-MRI, mpMRI)

Patients receive rhPSMA-7.3 IV then undergo PET-MRI and mpMRI of the prostate on study. Patients also undergo Decipher test at screening and MRI-PET prostate biopsy or radical prostatectomy within 90 days per standard of care.

Group Type: EXPERIMENTAL

Biopsy of Prostate

Intervention Type: PROCEDURE

Undergo MRI/PET prostate biopsy

Decipher Prostate Cancer Test

Intervention Type: GENETIC

Undergo decipher

Flotufolastat F-18 Gallium

Intervention Type: OTHER

Given IV

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo PET-MRI

Multiparametric Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo mpMRI

Positron Emission Tomography

Intervention Type: PROCEDURE

Undergo PET-MRI

Radical Prostatectomy

Intervention Type: PROCEDURE

Undergo radical prostatectomy

Interventions

Biopsy of Prostate

Undergo MRI/PET prostate biopsy

Intervention Type: PROCEDURE

Decipher Prostate Cancer Test

Undergo decipher

Intervention Type: GENETIC

Flotufolastat F-18 Gallium

Given IV

Intervention Type: OTHER

Magnetic Resonance Imaging

Undergo PET-MRI

Intervention Type: PROCEDURE

Multiparametric Magnetic Resonance Imaging

Undergo mpMRI

Intervention Type: PROCEDURE

Positron Emission Tomography

Undergo PET-MRI

Intervention Type: PROCEDURE

Radical Prostatectomy

Undergo radical prostatectomy

Intervention Type: PROCEDURE

Other Intervention Names

Prostate Biopsy; Prostatic Biopsy; Decipher; Decipher Metastasis Test; Decipher Test; (18F)-rhPSMA-7.3; 18F-rhPSMA-7.3; 18FrhPSMA-7.3; F-18-rhPSMA-7.3; Fluorine F 18 radiohybrid PSMA-7.3; Fluorine F 18 rhPSMA-7.3; Fluorine-18 rhPSMA-7.3; rhPSMA-7.3 (18F); Magnetic Resonance; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR; MR Imaging; MRI; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; MP-MRI; mpMRI; Multi-parametric MRI; Multiparametric MRI; Medical Imaging, Positron Emission Tomography; PET; PET Scan; Positron Emission Tomography Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging; PT; Prostatovesiculectomy

Eligibility Criteria

Inclusion Criteria

• Healthy men (Eastern Cooperative Oncology Group [ECOG] 0-1), >= 18 years old with at least 10 year life expectancy
• Histologically proven Gleason Grade Group 1 or 2 adenocarcinoma of the prostate
• Last prostate cancer containing biopsy performed within 3-15 months (mo.) prior to screening. Biopsy must have been >= 10 core biopsy and informed by prior mpMRI
• Prostate cancer categorized as low risk or favorable risk by National Comprehensive Cancer Network (NCCN) criteria (low risk is defined as T1c-T2a, prostate-specific antigen [PSA] < 10ng/ml, Gleason Grade Group 1 [Gleason 3+3=6] disease) and favorable intermediate risk as having no more than one of the following intermediate risk features, clinical T2b-T2c disease, PSA 10-20ng/ml, Gleason Grade Group 2 [Gleason score 3+4=7])
• Decipher genomic classifier score from prior biopsy >= 0.45
• Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures
• Concurrent diseases and malignancies are permitted
• Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on the study
• Willing to undergo prostate biopsy prior to non-surgical treatment of prostate cancer and within 90 days of PET-MRI imaging

Exclusion Criteria

• Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer
• NCCN very low risk category (T1c and Gleason Grade Group 1 [Gleason score 3+3=6], PSA < 10 ng/mL, fewer than 3 prostate biopsy cores positive, =< 50% cancer in any core, PSA density < 0.15 ng/mL/g)
• Decipher score < 0.45
• Prior bladder outlet procedure (i.e,. holmium laser enucleation of the prostate [HoLEP], transurethral resection of the prostate [TURP], Urolift, Rezum)
• Prohibited medications: use of 5 alpha reductase inhibitor or androgen deprivation therapy (i.e., leuprolide, relugolix) within 1 month of screening
• Contra-indication or relative contra-indication to MRI (i.e., pacemaker)
• History of hip replacement
• Subject has received investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Ashley Ross MD, PhD

Associate Professor, Department of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashley E Ross

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sophia Kallas

Role: CONTACT

sophia.kallas@northwestern.edu

312-694-9001

Nikki Hubbard

Role: CONTACT

nikki.hubbard@northwestern.edu

3126-694-9001

Facility Contacts

Ashley E. Ross

Role: primary

Ashley.ross@nm.org

312-694-9001

References

Jang JW, Abrams A, Jawahar A, Savas H, Yang XJ, Mehta V, Schnauss M, Schaeffer EM, Alam R, Ross AE. Detection of MRI-Invisible Disease Using PSMA PET/CT in a Patient Considering Focal Therapy. Case Rep Urol. 2025 Mar 26;2025:2981515. doi: 10.1155/criu/2981515. eCollection 2025.

Reference Type: DERIVED

PMID: 40177325 (View on PubMed)

Other Identifiers

NCI-2023-02187

Identifier Type: REGISTRY

Identifier Source: secondary_id

STU00218970

Identifier Type: -

Identifier Source: secondary_id

NU 22U05

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA060553

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NU 22U05

Identifier Type: -

Identifier Source: org_study_id