Study of High-dose Rate (HDR) Monotherapy for Low and Intermediate Risk Prostate Cancer
Phase 2
Active, not recruiting
- Conditions
- Prostate Cancer
- Interventions
- Radiation: HDR brachytherapy monotherapy
- Registration Number
- NCT02077335
- Lead Sponsor
- CSSS de Gatineau
- Brief Summary
The purpose of this study is to determine the clinical efficacy and toxicity of High-dose rate (HDR) brachytherapy as monotherapy for the treatment of low risk and intermediate risk prostate cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 50
Inclusion Criteria
- Biopsy proven Adenocarcinoma of the Prostate
- Clinical stage T1c, T2a or T2b
- PSA less than 20 ng/ml
- Gleason Score 6 or 7
Exclusion Criteria
- Age less than 18 years
- Clinical stage T2c, T3 ou T4
- Clinical Stage N1
- Clinical Stage M1
- Prostate Specific Antigen (PSA) more than 20 ng/ml
- Gleason score 8 or higher
- IPSS score 19 or higher with alpha-blockers
- Past radiation therapy to the pelvis
- History of Collagen Vascular Disease
- History of Inflammatory Bowel Disease
- Bilateral Hip Prosthesis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HDR brachytherapy monotherapy HDR brachytherapy monotherapy Radiation therapy: Treatment with 2 separate HDR brachytherapy implants, each with one fraction of 13.5 Gray (Gy) with an interval of 7-14 days between treatments.
- Primary Outcome Measures
Name Time Method Disease-free survival 5 years Disease free survival as evaluated by absence of biochemical recurrence (Phoenix criteria) and absence of clinically/radiologically diagnosed local, regional or distant recurrence.
- Secondary Outcome Measures
Name Time Method Genito-urinary (GU) toxicity 6 weeks, 2 years and 5 years post treatment Toxicity according to International prostate symptom score (IPSS) and Expanded Prostate Index Composite (EPIC) questionnaires.
Trial Locations
- Locations (1)
CSSS de Gatineau
🇨🇦Gatineau, Quebec, Canada