Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr
Status
RECRUITING
Phase
NA
Age
18 - 90 Years
Enrollments
200Conditions
Prostate CancerSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Timothy McClure, M.D.
Principal Investigator
- Timothy Mcclure, M.D.
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.
* Ability to complete HRQOL surveys (EPIC, IPSS, IIEF-5).
* 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.
Study Plan
PSMA-PET CT
OTHER
Patients will undergo PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) at baseline, 12 month and 24 month time point.
DIAGNOSTIC_TEST:
PSMA-PET CTDescription:
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 Outcome Measures
Negative predictive value (NPV)
Negative predictive value (NPV)
Negative predictive value (NPV)
Secondary Outcome Measures
Positive predictive value (PPV) of PSMA PET.
Positive predictive value (PPV) of PSMA PET.
Positive predictive value (PPV) of PSMA PET.
Number of patients with negative PSMA pet scan.
Number of patients with negative PSMA pet scan.
Number of patients with negative PSMA pet scan.
Number of positive scans on mpMRI
Number of positive scans on mpMRI
Number of positive scans on mpMRI
Number of positive scans on PSMA-PET
Number of positive scans on PSMA-PET
Number of positive scans on PSMA-PET
Number of positive scans on both PSMA-PET and mpMRI
Number of positive scans on both PSMA-PET and mpMRI
Number of positive scans on both PSMA-PET and mpMRI
Number of negative scans on mpMRI
Number of negative scans on mpMRI
Number of negative scans on mpMRI
Number of negative scans on PSMA-PET
Number of negative scans on PSMA-PET
Number of negative scans on PSMA-PET
Number of negative scans on both PSMA-PET and mpMRI
Number of negative scans on both PSMA-PET and mpMRI
Number of negative scans on both PSMA-PET and mpMRI
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.
Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.
Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.
Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.
Timeline
Last Updated
March 27, 2024Start Date
July 17, 2023Today
February 5, 2025Completion Date ( Estimated )
December 1, 2028
Sponsors of this trial
Lead Sponsor
Weill Medical College of Cornell University
RECRUITING 
21 - 64 Years