Multi-omic Approach to Study HDR Brachytherapy for Favorable Risk and Low Tier Intermediate Risk Prostate Cancer
Trial Parameters
Brief Summary
This is an observational single-center trial for patients with localized prostate cancer suitable for High Dose Rate (HDR) brachytherapy as monotherapy. This study takes a multi-omics approach to study the mechanism of action of HDR brachytherapy through metabolomics, immunological, transcriptomics, and spectroscopic profiling. The results of this study will clarify the optimal dose for HDR prostate brachytherapy by documenting the dose-response relationship seen in the changing tumor metabolites after HDR brachytherapy and investigate the immunogenicity of HDR brachytherapy.
Eligibility Criteria
Inclusion Criteria: * Favorable risk and intermediate-risk prostate cancer with estimated life expectancy of at least 10 years. * Clinical stage T1c-T2b, PSA \< 20, Gleason \< 8 * ECOG 0-1 * Low tier intermediate-risk prostate cancer is defined by: a single NCCN intermediate risk factor (either Gleason 7(3+4) and PSA \< 10 ng/ml OR Gleason 6 and PSA 10-20 ng/ml) * Extensive favorable-risk disease is defined as: clinical stage T1c-T2a, PSA \< 10, Gleason 6, ≥ 50% of biopsy cores containing cancer, PSA density \> 0.2 ng/cc, * Selected intermediate risk patients not defined above * T1c/T2a * PSA \< 10 and Gleason 4+3 * PSA \> 10 (\< 20) and Gleason 3+4 * PSA 10-15 ng/ml and Gleason 4+3 and \< 33% cores involved * Max tumor length in any core 10 mm * No androgen deprivation therapy (ADT) * Signed study specific informed consent. Exclusion Criteria: * Prior radical surgery for carcinoma of the prostate, * Prior pelvic radiation * Prior chemotherapy for prostate cancer, * Claustrophobic or u