ESCAPE - Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Weill Medical College of Cornell University
- Enrollment
- 200
- Locations
- 4
- Primary Endpoint
- Negative predictive value (NPV)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males aged ≥
- •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.
- •Initial diagnosis of prostate cancer greater than 15 months.
Outcomes
Primary Outcomes
Negative predictive value (NPV)
Time Frame: 24 months
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.
Secondary Outcomes
- Positive predictive value (PPV) of PSMA PET.(24 months)
- Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.(24 months)
- Number of positive scans on mpMRI(24 months)
- Number of negative scans on PSMA-PET(24 months)
- Number of patients with negative PSMA pet scan.(24 months)
- Number of positive scans on PSMA-PET(24 months)
- Number of negative scans on both PSMA-PET and mpMRI(24 months)
- Number of positive scans on both PSMA-PET and mpMRI(24 months)
- Number of negative scans on mpMRI(24 months)
- Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.(24 months)
- Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.(24 months)