Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr (ESCAPE)

ESCAPE - Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: PSMA-PET CT

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pragya Yadav, Ph.D.; Phone Number: 646-962-2199; Email: pry2003@med.cornell.edu
• Study Contact Backup: Name: Sharanya Chandrasekhar, M.S.; Phone Number: 646-962-3110; Email: shc2043@med.cornell.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90005
      • Not yet recruiting
      • UCLA
      • Contact: Pragya Yadav; Phone Number: 646-962-2199
      • Principal Investigator: Wayne Brisbane, M.D.
    • San Francisco, California, United States, 94143
      • Not yet recruiting
      • UCSF
      • Contact: Pragya Yadav; Phone Number: 646-962-2199; Email: pry2003@med.cornell.edu
      • Principal Investigator: Matthew Cooperberg, M.D.
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medicine - New York Presbyterian Hospital
      • Principal Investigator: Himanshu Nagar, M.D.
      • Contact: Timothy McClure, M.D.
      • Principal Investigator: Timothy McClure, M.D.
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Not yet recruiting
      • Case Western University Hospitals
      • Contact: Pragya Yadav; Phone Number: 646-962-2199; Email: pry2003@med.cornell.edu
      • Principal Investigator: Jonathan Shoag, M.D.
  • Texas
    • Dallas, Texas, United States, 75390
      • Not yet recruiting
      • UT Southwestern
      • Contact: Sharanya Chandrasekhar; Phone Number: 646-962-3110; Email: shc2043@med.cornell.edu
      • Contact: Pragya Yadav; Phone Number: 646-962-2196; Email: pry2003@med.cornell.edu
      • Principal Investigator: Solomon Woldu, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Himanshu Nagar, M.D., Weill Medical College of Cornell University; Principal Investigator: Timothy Mcclure, M.D., Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 23-03025893

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes