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

NCT05852041 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-22

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

Biopsy of Prostate

Undergo MRI/PET prostate biopsy

GENETIC

Decipher Prostate Cancer Test

Undergo decipher

OTHER

Flotufolastat F-18 Gallium

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo PET-MRI

PROCEDURE

Multiparametric Magnetic Resonance Imaging

Undergo mpMRI

PROCEDURE

Positron Emission Tomography

Undergo PET-MRI

PROCEDURE

Radical Prostatectomy

Undergo radical prostatectomy

Sponsors & Collaborators

Principal Investigators

  • Ashley E Ross · Northwestern University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-07
Primary Completion
2027-06-07
Completion
2035-06-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05852041 on ClinicalTrials.gov