RecruitingInterventional

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

NCT ID: NCT05948657Sponsor: Weill Medical College of Cornell UniversityLast updated: 2026-05-04

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.

Detailed 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.

Arms & 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.

Outcome measures

Primary

Negative predictive value (NPV)
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.
Time frame: Baseline
Negative predictive value (NPV)
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.
Time frame: 12 months
Negative predictive value (NPV)
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.
Time frame: 24 months

Secondary

Positive predictive value (PPV) of PSMA PET.
Time frame: Baseline
Positive predictive value (PPV) of PSMA PET.
Time frame: 12 months
Positive predictive value (PPV) of PSMA PET.
Time frame: 24 months
Number of patients with negative PSMA pet scan.
Time frame: Baseline
Number of patients with negative PSMA pet scan.
Time frame: 12 months
Number of patients with negative PSMA pet scan.
Time frame: 24 months
Number of positive scans on mpMRI
Time frame: Baseline
Number of positive scans on mpMRI
Time frame: 12 months
Number of positive scans on mpMRI
Time frame: 24 months
Number of positive scans on PSMA-PET
Time frame: Baseline
Number of positive scans on PSMA-PET
Time frame: 12 months
Number of positive scans on PSMA-PET
Time frame: 24 months
Number of positive scans on both PSMA-PET and mpMRI
Time frame: Baseline
Number of positive scans on both PSMA-PET and mpMRI
Time frame: 12 months
Number of positive scans on both PSMA-PET and mpMRI
Time frame: 24 months
Number of negative scans on mpMRI
Time frame: Baseline
Number of negative scans on mpMRI
Time frame: 12 months
Number of negative scans on mpMRI
Time frame: 24 months
Number of negative scans on PSMA-PET
Time frame: Baseline
Number of negative scans on PSMA-PET
Time frame: 12 months
Number of negative scans on PSMA-PET
Time frame: 24 months
Number of negative scans on both PSMA-PET and mpMRI
Time frame: Baseline
Number of negative scans on both PSMA-PET and mpMRI
Time frame: 12 months
Number of negative scans on both PSMA-PET and mpMRI
Time frame: 24 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.
Time frame: Baseline
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.
Time frame: 12 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.
Time frame: 24 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.
Time frame: Baseline
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.
Time frame: 12 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.
Time frame: 24 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.
Time frame: Baseline
Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.
Time frame: 12 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.
Time frame: 24 months

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy 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 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 locations (4)

UCLA

Los Angeles, California, 90005

Not Yet Recruiting

Sarah Yuan · Contact

say7008@med.cornell.edu

Wayne Brisbane, M.D. · Principal Investigator

UCSF

San Francisco, California, 94143

Not Yet Recruiting

Sarah Yuan · Contact

say7008@med.cornell.edu

Matthew Cooperberg, M.D. · Principal Investigator

Weill Cornell Medicine - New York Presbyterian Hospital

New York, New York, 10065

Recruiting

Timothy McClure, M.D. · Contact

tim9047@med.cornell.edu

Timothy McClure, M.D. · Principal Investigator

UH Cleveland Medical Center

Cleveland, Ohio, 44106

Recruiting

Matt Ferrebee · Contact

Matthew.Ferrebee@UHhospitals.org

Jonathan Shoag, M.D. · Principal Investigator