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

Prostate Cancer Clinical Trial

— ESCAPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05948657
• Other study ID #: 23-03025893
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2024
• Est. completion date: December 2028

Study information

• Verified date: March 2024
• Source: Weill Medical College of Cornell University
• Contact: Pragya Yadav, Ph.D.
• Phone: 646-962-2199
• Email: pry2003[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2028
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Case Western University Hospitals	Cleveland	Ohio
United States	UT Southwestern	Dallas	Texas
United States	UCLA	Los Angeles	California
United States	Weill Cornell Medicine - New York Presbyterian Hospital	New York	New York
United States	UCSF	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of patients with negative PSMA pet scan.		Baseline
Secondary	Number of patients with negative PSMA pet scan.		12 months
Secondary	Number of patients with negative PSMA pet scan.		24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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