An interventional study of PSMA-PET CT in Prostate Cancer, sponsored by Weill Medical College of Cornell University. Recruiting at 4 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Diagnostic
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 200 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.
Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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.
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
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.
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
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
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Weill Medical College of Cornell University