Study of High-dose Rate (HDR) Monotherapy for Low and Intermediate Risk Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
HDR brachytherapy monotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Brachytherapy, Monotherapy, HDR
Eligibility Criteria
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
Sites / Locations
- CSSS de Gatineau
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HDR brachytherapy monotherapy
Arm Description
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.
Outcomes
Primary Outcome Measures
Disease-free survival
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
Genito-urinary (GU) toxicity
Toxicity according to International prostate symptom score (IPSS) and Expanded Prostate Index Composite (EPIC) questionnaires.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02077335
Brief Title
Study of High-dose Rate (HDR) Monotherapy for Low and Intermediate Risk Prostate Cancer
Official Title
Phase II Study of High-dose Rate (HDR) Monotherapy for the Treatment of Low and Intermediate Risk Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CSSS de Gatineau
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Brachytherapy, Monotherapy, HDR
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HDR brachytherapy monotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
HDR brachytherapy monotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease-free survival
Description
Disease free survival as evaluated by absence of biochemical recurrence (Phoenix criteria) and absence of clinically/radiologically diagnosed local, regional or distant recurrence.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Genito-urinary (GU) toxicity
Description
Toxicity according to International prostate symptom score (IPSS) and Expanded Prostate Index Composite (EPIC) questionnaires.
Time Frame
6 weeks, 2 years and 5 years post treatment
Other Pre-specified Outcome Measures:
Title
Overall survival
Time Frame
5 years
Title
Gastro-Intestinal (GI) Toxicity
Description
Toxicity according to Expanded Prostate Index Composite (EPIC) questionnaires.
Time Frame
6 weeks, 2 years and 5 years post treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CSSS de Gatineau
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8P 7H2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of High-dose Rate (HDR) Monotherapy for Low and Intermediate Risk Prostate Cancer
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