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PSMA-PET CT for Prostate Cancer on Active Surveillance

This study is looking at how well a special scan called PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) can tell if prostate cancer is not getting worse in men who are on active surveillance. Active surveillance means closely watching the cancer instead of treating it right away. The study will involve 200 men who have low or favorable intermediate-risk prostate cancer and a PSA level below 20 ng/ml. You would need to be able to have yearly PSMA-PET CT scans and yearly prostate mpMRI scans. The main goal is to see how accurate the PSMA-PET CT is at showing that there is no significant cancer at the start, and then again after 12 and 24 months.

Study design
This is a single-arm study, meaning all 200 participants will receive the same intervention. It is not randomized, and the phase is not specified.
What's involved
You would undergo PSMA-PET CT scans at the beginning of the study, and again after 12 months and 24 months. You would also need to be able to undergo yearly prostate mpMRI scans.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for at least 24 months, with measurements taken at baseline, 12 months, and 24 months.

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

NCT05948657

Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr

Recruiting
NAAges 18+InterventionalDiagnostic
Weill Medical College of Cornell University
~200 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:PSMA-PET CT

At a glance

Recruiting sites
2 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Negative predictive value (NPV)
Measured over Baseline
+2 more outcomes measured

Conditions

Prostate Cancer

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Where it's being run

4 sites across 3 states
California2
New York1
Ohio1

Study leadership

  • Timothy McClure, M.D. · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University

Who to contact

Holly Kuczynski
[email protected]
646-962-7523
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Males aged ≥ 18.
Histologically confirmed low or favorable intermediate risk prostate cancer per NCCN guidelines. (Note: Grade Group 2 must have 20% or less involvement in every core and no presence of cribiform or intraductal carcinoma).
PSA \< 20 ng/ml.
Ability to undergo yearly PSMA-PET CT.
Ability to undergo yearly prostate mpMRI.
Ability to undergo transrectal or transperineal template and fusion prostate biopsy.
Willingness to undergo yearly prostate biopsies.

Exclusion

History of prior treatment for prostate cancer.
History of systemic therapy for prostate cancer.
Inability to undergo transrectal ultrasound.
Life expectancy less than 10 years.
Not interested in pursuing active surveillance.
Initial diagnosis of prostate cancer greater than 15 months.

What this trial measures

  • Negative predictive value (NPV)Baseline

    Negative predictive value (NPV): The NPV is defined as the number of negative image results with identified clinically insignificant prostate cancer on biopsy divided by the number of negative image results.

  • Negative predictive value (NPV)12 months

    Negative predictive value (NPV): The NPV is defined as the number of negative image results with identified clinically insignificant prostate cancer on biopsy divided by the number of negative image results.

  • Negative predictive value (NPV)24 months

    Negative predictive value (NPV): The NPV is defined as the number of negative image results with identified clinically insignificant prostate cancer on biopsy divided by the number of negative image results.