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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSMA-PET CT | Other | Patients will undergo PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) at baseline, 12 month and 24 month time point. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSMA-PET CT | Diagnostic Test | Patients will undergo PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) at baseline, 12 month and 24 month time point. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Positive predictive value (PPV) of PSMA PET. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Holly Kuczynski | Contact | 646-962-7523 | hok4001@med.cornell.edu | |
| Sarah Yuan | Contact | 646-962-6040 | say7008@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Timothy McClure, M.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Not yet recruiting | Los Angeles | California | 90005 | United States |
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Patients will undergo PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) at baseline, 12 month and 24 month time point.
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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. |
| 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. | 24 months |
| Number of patients with negative PSMA pet scan. | Baseline |
| Number of patients with negative PSMA pet scan. | 12 months |
| Number of patients with negative PSMA pet scan. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 24 months |
| UCSF | Not yet recruiting | San Francisco | California | 94143 | United States |
|
| Weill Cornell Medicine - New York Presbyterian Hospital | Recruiting | New York | New York | 10065 | United States |
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| UH Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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