ESCAPE - Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr
Weill Medical College of Cornell University
Summary
This study will be assessing the ability of PSMA-PET CT to determine the absence of clinically significant prostate cancer in patients on active surveillance (AS) with low risk and favorable intermediate-risk prostate cancer.
Description
This is a prospective, multicenter, nonrandomized single-arm study assessing the diagnostic accuracy of PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) in determining the absence of clinically significant prostate cancer in patients on active surveillance (AS).The trial will enroll 200 subjects for low and favorable intermediate-risk prostate cancer patients per NCCN guidelines who have elected to pursue active surveillance.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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…
Interventions
- Diagnostic TestPSMA-PET CT
Patients will undergo PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) at baseline, 12 month and 24 month time point.
Locations (4)
- UCLALos Angeles, California
- UCSFSan Francisco, California
- Weill Cornell Medicine - New York Presbyterian HospitalNew York, New York
- UH Cleveland Medical CenterCleveland, Ohio