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

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Diagnostic Test: PSMA-PET CT

Study type: Interventional

Funder types: Other

Identifiers

NCT05948657

23-03025893

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

PSMA-PET CT

Other group

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.

Treatment:

Diagnostic Test: PSMA-PET CT