Prostate Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTPSMA-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.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Patients will undergo PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) at baseline, 12 month and 24 month time point.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Negative predictive value (NPV) | Baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| Positive predictive value (PPV) of PSMA PET. | Baseline | 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 with negative PSMA pet scan. | Baseline | — |
| Number of positive scans on mpMRI | Baseline | 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 positive scans on PSMA-PET | Baseline | 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 positive scans on both PSMA-PET and mpMRI | Baseline | 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 | Baseline | 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 negative scans on PSMA-PET | Baseline | 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 negative scans on both PSMA-PET and mpMRI | Baseline | 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 PSMA-PET. | Baseline | 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 by mpMRI. | Baseline | 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. | Baseline | 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. |
Countries
United States
Contacts
CONTACTHolly Kuczynski
CONTACTSarah Yuan
PRINCIPAL_INVESTIGATORTimothy McClure, M.D.
Weill Medical College of Cornell University
Outcome results
None listed