Multi-omic Approach to Study HDR Brachytherapy for Favorable Risk and Low Tier Intermediate Risk Prostate Cancer
Recruiting · NCT06200974 · Observational (researchers observe without assigning treatment) · Lead sponsor: British Columbia Cancer Agency
View the official record on ClinicalTrials.gov →Interventions studied
High dose rate prostate brachytherapy
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
1 location listed.
- British Columbia Cancer Center for the Southern Interior - Kelowna, British Columbia, Canada