RecruitingNCT06200974

Multi-omic Approach to Study HDR Brachytherapy for Favorable Risk and Low Tier Intermediate Risk Prostate Cancer

Multi-omic Approach to Study High Dose Rate (HDR) Brachytherapy for Favorable Risk and Low Tier Intermediate Risk Prostate Cancer

Sponsor

British Columbia Cancer Agency

Enrollment

100 participants

Start Date

Feb 1, 2024

Study Type

OBSERVATIONAL

Conditions

Localized Prostate Carcinoma

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

Min Age: 18 Years

Inclusion Criteria13

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 Criteria5

Prior radical surgery for carcinoma of the prostate,
Prior pelvic radiation
Prior chemotherapy for prostate cancer,
Claustrophobic or unable to undergo MRI
Patients unsuitable for general anesthesia, on blood thinners which cannot be stopped for 24 hours, or who have contraindications to radiotherapy such as systemic sclerosis, or inflammatory bowel disease

Interventions

RADIATIONHigh dose rate prostate brachytherapy

Temporary implantation of radioactive material into the prostate in the form of a stepping source of Iridium 192 that travels through 16-18 needles or catheters strategically placed through the prostate.