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NCT05948657NARecruiting

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

Weill Medical College of Cornell University

Start Date

2/26/2024

Completion Date

12/1/2028

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

Age Range: 18 years to No maximum

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. * 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.

Interventions

DIAGNOSTIC_TEST

PSMA-PET CT

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Conditions

Prostate Cancer

Locations

UCLA

Los Angeles, California 90005

United States

UCSF

San Francisco, California 94143

United States

Weill Cornell Medicine - New York Presbyterian Hospital

New York, New York 10065

United States

UH Cleveland Medical Center

Cleveland, Ohio 44106

United States