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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
Patients will undergo PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) at baseline, 12 month and 24 month time point.
UCLA
Los Angeles, California, United States
NOT_YET_RECRUITINGUCSF
San Francisco, California, United States
NOT_YET_RECRUITINGWeill Cornell Medicine - New York Presbyterian Hospital
New York, New York, United States
RECRUITINGNegative 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
Positive predictive value (PPV) of PSMA PET.
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.
Time frame: Baseline
Positive predictive value (PPV) of PSMA PET.
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.
Time frame: 12 months
Positive predictive value (PPV) of PSMA PET.
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.
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UH Cleveland Medical Center
Cleveland, Ohio, United States
RECRUITINGTime 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
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.
Time frame: Baseline
Number of positive scans on mpMRI
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.
Time frame: 12 months
Number of positive scans on mpMRI
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.
Time frame: 24 months
Number of positive scans on PSMA-PET
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.
Time frame: Baseline
Number of positive scans on PSMA-PET
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.
Time frame: 12 months
Number of positive scans on PSMA-PET
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.
Time frame: 24 months
Number of positive scans on both PSMA-PET and mpMRI
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.
Time frame: Baseline
Number of positive scans on both PSMA-PET and mpMRI
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.
Time frame: 12 months
Number of positive scans on both PSMA-PET and mpMRI
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.
Time frame: 24 months
Number of negative scans on mpMRI
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.
Time frame: Baseline
Number of negative scans on mpMRI
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.
Time frame: 12 months
Number of negative scans on mpMRI
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.
Time frame: 24 months
Number of negative scans on PSMA-PET
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.
Time frame: Baseline
Number of negative scans on PSMA-PET
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.
Time frame: 12 months
Number of negative scans on PSMA-PET
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.
Time frame: 24 months
Number of negative scans on both PSMA-PET and mpMRI
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.
Time frame: Baseline
Number of negative scans on both PSMA-PET and mpMRI
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.
Time frame: 12 months
Number of negative scans on both PSMA-PET and mpMRI
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.
Time frame: 24 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.
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.
Time frame: Baseline
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.
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.
Time frame: 12 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.
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.
Time frame: 24 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.
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.
Time frame: Baseline
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.
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.
Time frame: 12 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.
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.
Time frame: 24 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.
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.
Time frame: Baseline
Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.
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.
Time frame: 12 months
Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.
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.
Time frame: 24 months