Prostate Cancer Clinical Trial
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.
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.
Males aged â‰¥ 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.
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.
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