New scan could spot hidden aggressive prostate cancer in men who think They're safe
NCT ID NCT05852041
First seen Jul 02, 2026 · Last updated Jul 02, 2026
Summary
This study tests whether a special PET-MRI scan using a radioactive tracer called rhPSMA-7.3 can find higher-risk prostate cancer that standard tests might miss. Men with low-risk or favorable intermediate-risk prostate cancer who are candidates for active surveillance will receive the scan before a prostate biopsy. The goal is to see if the scan better identifies those who actually need treatment rather than just monitoring.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Flotufolastat F-18 Gallium (rhPSMA-7.3)
- What this could lead to
- If successful, this imaging method could help identify men who need immediate treatment rather than active surveillance, potentially catching aggressive prostate cancer earlier.
- What could go wrong
- This is a small early-phase pilot study, so results may not apply broadly. The radioactive tracer may not reliably distinguish aggressive from slow-growing cancers, and there are risks from radiation exposure and biopsy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Jun 2035
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Northwestern University
RECRUITINGChicago, Illinois, 60611, United States
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Other studies related to the condition(s) this trial covers.
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- Can a High-Tech radiation beam hit prostate tumors without harming healthy tissue?
- Can MRI-Guided radiation zero in on prostate tumors with fewer side effects?