Actively Recruiting
rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance
Led by Northwestern University · Updated on 2025-05-22
40
Participants Needed
1
Research Sites
626 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy men with ECOG performance status 0-1, aged 18 years or older, with at least 10 years life expectancy
- Histologically confirmed Gleason Grade Group 1 or 2 prostate adenocarcinoma
- Last prostate cancer biopsy performed within 3 to 15 months before screening, with at least 10 cores informed by prior mpMRI
- Prostate cancer classified as low risk or favorable intermediate risk by NCCN criteria
- Decipher genomic classifier score from prior biopsy of 0.45 or higher
- Ability and willingness to provide written informed consent
- Willingness to undergo prostate biopsy within 90 days of PET-MRI imaging
- Concurrent diseases and other malignancies are allowed
You will not qualify if you...
- Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer
- Very low risk prostate cancer by NCCN criteria
- Decipher score below 0.45
- Prior bladder outlet procedures such as HoLEP, TURP, Urolift, or Rezum
- Use of 5 alpha reductase inhibitor or androgen deprivation therapy within 1 month of screening
- Contraindications to MRI including having a pacemaker
- History of hip replacement
- Received investigational therapy within 28 days or 5 half-lives before screening
AI-Screening
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Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
S
Sophia Kallas
CONTACT
N
Nikki Hubbard
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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