Study of High-dose Rate (HDR) Monotherapy for Low and Intermediate Risk Prostate Cancer
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of High-dose Rate (HDR) Monotherapy for the Treatment of Low and Intermediate Risk Prostate Cancer|
- Disease-free survival [ Time Frame: 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.
- Genito-urinary (GU) toxicity [ Time Frame: 6 weeks, 2 years and 5 years post treatment ]Toxicity according to International prostate symptom score (IPSS) and Expanded Prostate Index Composite (EPIC) questionnaires.
- Overall survival [ Time Frame: 5 years ]
- Gastro-Intestinal (GI) Toxicity [ Time Frame: 6 weeks, 2 years and 5 years post treatment ]Toxicity according to Expanded Prostate Index Composite (EPIC) questionnaires.
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||September 2022|
|Estimated Primary Completion Date:||September 2022 (Final data collection date for primary outcome measure)|
Experimental: 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.
Radiation: HDR brachytherapy monotherapy
Radiation therapy in the study consists of treatment with 2 separate interstitial HDR brachytherapy procedures with temporary interstitial catheters, each with one fraction of 13.5 Gray (Gy). Both procedures will be done in an identical manner. The 2 procedures will be separated by an interval of 7-14 days Treatments will be done with interstitial catheters inserted transperineally with transrectal ultrasound guidance under sterile conditions. Optimization of treatment plan will be done with Brachyvision software (Varian, Palo Alto CA) based on CT-scan imaging done post-implant. Optimization parameters will be the following:
• V75 < 1cc
• V75 < 1cc
V125 = 0cc D10 < 120%
Treatments will be carried out with an Iridium-192 afterloader. Source and all catheters will be removed from the patient at the end of the procedure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02077335
|CSSS de Gatineau|
|Gatineau, Quebec, Canada, J8P 7H2|