Clinical trial NCT05948657: Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr
Official title: ESCAPE - Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.
* Ability to complete HRQOL surveys (EPIC, IPSS, IIEF-5).
* 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.

Primary outcomes:
measure: Negative predictive value (NPV)
timeFrame: Baseline
measure: Negative predictive value (NPV)
timeFrame: 12 months
measure: Negative predictive value (NPV)
timeFrame: 24 months
Secondary outcomes:
measure: Positive predictive value (PPV) of PSMA PET.
timeFrame: Baseline
measure: Positive predictive value (PPV) of PSMA PET.
timeFrame: 12 months
measure: Positive predictive value (PPV) of PSMA PET.
timeFrame: 24 months
measure: Number of patients with negative PSMA pet scan.
timeFrame: Baseline
measure: Number of patients with negative PSMA pet scan.
timeFrame: 12 months
measure: Number of patients with negative PSMA pet scan.
timeFrame: 24 months
measure: Number of positive scans on mpMRI
timeFrame: Baseline
measure: Number of positive scans on mpMRI
timeFrame: 12 months
measure: Number of positive scans on mpMRI
timeFrame: 24 months
measure: Number of positive scans on PSMA-PET
timeFrame: Baseline
measure: Number of positive scans on PSMA-PET
timeFrame: 12 months
measure: Number of positive scans on PSMA-PET
timeFrame: 24 months
measure: Number of positive scans on both PSMA-PET and mpMRI
timeFrame: Baseline
measure: Number of positive scans on both PSMA-PET and mpMRI
timeFrame: 12 months
measure: Number of positive scans on both PSMA-PET and mpMRI
timeFrame: 24 months
measure: Number of negative scans on mpMRI
timeFrame: Baseline
measure: Number of negative scans on mpMRI
timeFrame: 12 months
measure: Number of negative scans on mpMRI
timeFrame: 24 months
measure: Number of negative scans on PSMA-PET
timeFrame: Baseline
measure: Number of negative scans on PSMA-PET
timeFrame: 12 months
measure: Number of negative scans on PSMA-PET
timeFrame: 24 months
measure: Number of negative scans on both PSMA-PET and mpMRI
timeFrame: Baseline
measure: Number of negative scans on both PSMA-PET and mpMRI
timeFrame: 12 months
measure: Number of negative scans on both PSMA-PET and mpMRI
timeFrame: 24 months
measure: Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.
timeFrame: Baseline
measure: Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.
timeFrame: 12 months
measure: Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.
timeFrame: 24 months
measure: Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.
timeFrame: Baseline
measure: Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.
timeFrame: 12 months
measure: Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.
timeFrame: 24 months
measure: Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.
timeFrame: Baseline
measure: Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.
timeFrame: 12 months
measure: Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.
timeFrame: 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: New York
country: United States
facility: Weill Cornell Medicine - New York Presbyterian Hospital
state: New York
city: Cleveland
country: United States
facility: Case Western University Hospitals
state: Ohio
Study officials:
affiliation: Weill Medical College of Cornell University
name: Timothy McClure, M.D.
role: PRINCIPAL_INVESTIGATOR
References: