Overview
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.
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.
- Initial diagnosis of prostate cancer greater than 15 months.