Study of High-dose Rate (HDR) Monotherapy for Low and Intermediate Risk Prostate Cancer
|ClinicalTrials.gov Identifier: NCT02077335|
Recruitment Status : Active, not recruiting
First Posted : March 4, 2014
Last Update Posted : January 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: HDR brachytherapy monotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of High-dose Rate (HDR) Monotherapy for the Treatment of Low and Intermediate Risk Prostate Cancer|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2022|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02077335
|CSSS de Gatineau|
|Gatineau, Quebec, Canada, J8P 7H2|