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Clinical trial Recruiting at 2 sites Interventional Ages 18 and up Men only

Using PSMA-PET CT to monitor prostate cancer in patients on active surveillance

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

Run by Weill Medical College of Cornell University · NCT05948657 · Data updated 2026-11-12

This study is testing if PSMA-PET CT scans can help men with low-risk prostate cancer on active surveillance see if they still have significant cancer or not.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment200 (estimated)
SponsorWeill Medical College of Cornell University
Academic / other
Locations4 sites (Los Angeles, California and 3 other locations)
StatusRecruiting
StartedFebruary 26, 2024
Main results expectedDecember 2028
Study endsDecember 2028
Registry record updatedMay 4, 2026
Trial IDNCT05948657 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are males aged 18 and older with histologically confirmed low or favorable intermediate-risk prostate cancer who are pursuing active surveillance.

Probably not a fit

Patients who have previously received treatment for prostate cancer or those with a life expectancy of less than 10 years may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of PSMA-PET CT imaging in identifying the absence of clinically significant prostate cancer in men who are on active surveillance for low and favorable intermediate-risk prostate cancer. It is a prospective, multicenter, nonrandomized single-arm study that aims to enroll 200 participants who meet specific NCCN guidelines. The study will assess the diagnostic accuracy of this imaging technique over time, with participants undergoing yearly PSMA-PET CT scans and prostate biopsies to monitor their condition.

Why it matters

Potential benefit: If successful, this study could provide a more accurate method for monitoring prostate cancer, potentially reducing unnecessary treatments for patients.

How similar studies have gone: Other studies have shown promise in using advanced imaging techniques for cancer monitoring, but this specific approach with PSMA-PET CT in active surveillance is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

  • Weill Cornell Medicine - New York Presbyterian Hospital
    New York, New York, United States     Recruiting
  • UH Cleveland Medical Center
    Cleveland, Ohio, United States     Recruiting
  • UCLA
    Los Angeles, California, United States     Not yet recruiting
  • UCSF
    San Francisco, California, United States     Not yet recruiting

Study contacts

  • Principal investigator: Timothy McClure, M.D. — Weill Medical College of Cornell University
  • Study coordinator: Holly Kuczynski
  • Email: hok4001@med.cornell.edu
  • Phone: 646-962-7523

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.