Prostate Cancer
Conditions
Keywords
Brachytherapy, Monotherapy, HDR
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.
Interventions
RADIATIONHDR 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: Prostate : * V100 \> 95% * V150 30-35% * V200 \< 15% * D90 \> 90% (12,15Gy) Bladder • V75 \< 1cc Rectum • V75 \< 1cc Urethra 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.
Sponsors
CSSS de Gatineau
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 years | — |
| Gastro-Intestinal (GI) Toxicity | 6 weeks, 2 years and 5 years post treatment | Toxicity according to Expanded Prostate Index Composite (EPIC) questionnaires. |
Countries
Canada
Outcome results
None listed