Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr
- Conditions
- Prostate Cancer
- Interventions
- Diagnostic Test: PSMA-PET CT
- Registration Number
- NCT05948657
- Lead Sponsor
- Weill Medical College of Cornell University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 200
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PSMA-PET CT PSMA-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.
- Primary Outcome Measures
Name Time Method Negative predictive value (NPV) 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 Outcome Measures
Name Time Method Positive predictive value (PPV) of PSMA PET. 24 months PPV of PSMA PET. Positive predictive value (PPV): The PPV is defined as the number of positive image results with identified csPCa on biopsy divided by the number of positive image results.
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET. 24 months The proportion of csPCa detected by PSMA-PET, mpMRI, and the combination. Proportion of patients with csPCa: this will be the number of patients identified as having csPCa divided by the number of patients with a biopsy.
Number of positive scans on mpMRI 24 months Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Sensitivity: The sensitivity will be defined as the number of positive image results with a csPCa upon biopsy divided by the number of biopsied patients with csPCa following the imaging.Number of negative scans on PSMA-PET 24 months Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Specificity: The specificity is defined as the number of negative image results followed by the absence of csPCa in the corresponding biopsy divided by the number of biopsies that did not identify csPCa.Number of patients with negative PSMA pet scan. 24 months Number of positive scans on PSMA-PET 24 months Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Sensitivity: The sensitivity will be defined as the number of positive image results with a csPCa upon biopsy divided by the number of biopsied patients with csPCa following the imaging.Number of negative scans on both PSMA-PET and mpMRI 24 months Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Specificity: The specificity is defined as the number of negative image results followed by the absence of csPCa in the corresponding biopsy divided by the number of biopsies that did not identify csPCa.Number of positive scans on both PSMA-PET and mpMRI 24 months Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Sensitivity: The sensitivity will be defined as the number of positive image results with a csPCa upon biopsy divided by the number of biopsied patients with csPCa following the imaging.Number of negative scans on mpMRI 24 months Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.
Specificity: The specificity is defined as the number of negative image results followed by the absence of csPCa in the corresponding biopsy divided by the number of biopsies that did not identify csPCa.Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI. 24 months The proportion of csPCa detected by PSMA-PET, mpMRI, and the combination. Proportion of patients with csPCa: this will be the number of patients identified as having csPCa divided by the number of patients with a biopsy.
Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI. 24 months The proportion of csPCa detected by PSMA-PET, mpMRI, and the combination. Proportion of patients with csPCa: this will be the number of patients identified as having csPCa divided by the number of patients with a biopsy.
Trial Locations
- Locations (4)
UCLA
🇺🇸Los Angeles, California, United States
UCSF
🇺🇸San Francisco, California, United States
Weill Cornell Medicine - New York Presbyterian Hospital
🇺🇸New York, New York, United States
Case Western University Hospitals
🇺🇸Cleveland, Ohio, United States