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

NCT05948657 · Weill Medical College of Cornell University
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Official title
ESCAPE - Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr
About this study
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 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.
Study design
Enrollment target: 200 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-02-26
Estimated completion: 2028-12
Last updated: 2026-02-27
Interventions
Diagnostic Test: PSMA-PET CT
Primary outcomes
  • Negative predictive value (NPV) (Baseline)
  • Negative predictive value (NPV) (12 months)
  • Negative predictive value (NPV) (24 months)
Sponsor
Weill Medical College of Cornell University · other
Contacts & investigators
ContactHolly Kuczynski · contact · hok4001@med.cornell.edu · 646-962-7523
ContactSarah Yuan · contact · say7008@med.cornell.edu · 646-962-6040
InvestigatorTimothy McClure, M.D. · principal_investigator, Weill Medical College of Cornell University
All locations (4)
UCLANot Yet Recruiting
Los Angeles, California, United States
UCSFNot Yet Recruiting
San Francisco, California, United States
Weill Cornell Medicine - New York Presbyterian HospitalRecruiting
New York, New York, United States
Case Western University HospitalsNot Yet Recruiting
Cleveland, Ohio, United States
Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr · TrialPath