Investigating HDR Brachytherapy for Prostate Cancer
Multi-omic Approach to Study High Dose Rate (HDR) Brachytherapy for Favorable Risk and Low Tier Intermediate Risk Prostate Cancer
This study is testing how effective High Dose Rate brachytherapy is for treating localized prostate cancer and looking at how it affects tumor changes and the immune system.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | British Columbia Cancer Agency Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Kelowna, British Columbia) |
| Trial ID | NCT06200974 on ClinicalTrials.gov |
What this trial studies
This observational trial focuses on patients with localized prostate cancer who are suitable for High Dose Rate (HDR) brachytherapy as a standalone treatment. Utilizing a multi-omics approach, the study aims to explore the mechanisms of HDR brachytherapy through various profiling techniques, including metabolomics, immunological assessments, transcriptomics, and spectroscopic analysis. The research will document the dose-response relationship of HDR brachytherapy by measuring changes in tumor metabolites and evaluating immune responses before and after treatment. The goal is to clarify the optimal dosing for HDR brachytherapy and its immunogenic effects.
Who should consider this trial
Good fit: Ideal candidates include men with favorable risk and low tier intermediate risk prostate cancer, with specific clinical and biological criteria.
Not a fit: Patients with prior radical surgery, pelvic radiation, or chemotherapy for prostate cancer are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness of HDR brachytherapy, potentially improving cure rates for patients with localized prostate cancer.
How similar studies have performed: While HDR brachytherapy has been previously studied, this multi-omics approach is relatively novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Kelowna, British Columbia
- British Columbia Cancer Center for the Southern Interior — Kelowna, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Juanita M Crook, MD — Radiation Oncologist
- Study coordinator: Juanita M Crook, MD
- Email: jcrook@bccancer.bc.ca
- Phone: 250 712 3958
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.