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PET-MRI Imaging for Prostate Cancer Detection

This study is looking at whether a special type of imaging called PET-MRI, using a drug called Flotufolastat F-18 Gallium (rhPSMA-7.3), can help find more serious prostate cancer in men who are currently on active surveillance. Active surveillance means closely watching the cancer instead of treating it right away. The study aims to see if this PET-MRI can detect higher-grade or more advanced prostate cancer that might have been missed by standard tests. You might be able to join if you are a man at least 18 years old, in good health, with a life expectancy of at least 10 years, and have a confirmed diagnosis of low- or intermediate-risk prostate cancer (Gleason Grade Group 1 or 2) from a biopsy done within the last 3 to 15 months. The study will consider it successful if this imaging method finds higher-grade or advanced disease in at least 15% of participants. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 40 participants. It is designed to evaluate the effectiveness of rhPSMA-7.3 PET-MRI.
What's involved
You would receive Flotufolastat F-18 Gallium (rhPSMA-7.3) intravenously, then undergo PET-MRI and mpMRI scans. You would also have a Decipher test and a prostate biopsy or surgery within 90 days.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured up to 90 days after the imaging.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05852041

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalDiagnostic
Northwestern University
~40 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Biopsy of ProstateDecipher Prostate Cancer TestFlotufolastat F-18 GalliumMagnetic Resonance ImagingMultiparametric Magnetic Resonance ImagingPositron Emission Tomography

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Radio-pathological correlation between positron emession tomography-magnetic resonance imaging (PET-MRI) and prostate biopsy or radical prostatectomy
Measured over Up to 90 days

Conditions

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

Explore related trials

Prostate CarcinomaDecipher

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Ashley E Ross · PRINCIPAL_INVESTIGATOR · Northwestern University

Who to contact

Sophia Kallas
[email protected]
312-694-9001
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Radio-pathological correlation between positron emession tomography-magnetic resonance imaging (PET-MRI) and prostate biopsy or radical prostatectomyUp to 90 days

    Will report agreement between pathology and imaging and ability of radiohybrid prostate-specific membrane antigen-7-PET-MRI to identify higher grade and stage disease as a raw percentage.