Status:
RECRUITING
Multi-omic Approach to Study HDR Brachytherapy for Favorable Risk and Low Tier Intermediate Risk Prostate Cancer
Lead Sponsor:
British Columbia Cancer Agency
Collaborating Sponsors:
BC Cancer Foundation
University of British Columbia
Conditions:
Localized Prostate Carcinoma
Eligibility:
All Genders
18+ years
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 stud...
Detailed Description
High Dose Rate (HDR) prostate brachytherapy is an effective and highly conformal means of delivering curative radiation to the prostate. Because of the high dose rate, initial studies applied this tre...
Eligibility Criteria
Inclusion
- 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 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
- 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
Key Trial Info
Start Date :
February 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2038
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06200974
Start Date
February 1 2024
End Date
February 1 2038
Last Update
April 15 2024
Active Locations (1)
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1
British Columbia Cancer Center for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3