Using PSMA-PET CT to monitor prostate cancer in patients on active surveillance
ESCAPE - Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 4 sites (Los Angeles, California and 3 other locations) |
| Trial ID | NCT05948657 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Los Angeles, California and 3 other locations
- UCLA — Los Angeles, California, United States (Not_yet_recruiting)
- UCSF — San Francisco, California, United States (Not_yet_recruiting)
- Weill Cornell Medicine - New York Presbyterian Hospital — New York, New York, United States (Recruiting)
- UH Cleveland Medical Center — Cleveland, Ohio, United States (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.