Status:
COMPLETED
Safety and Efficacy Study of Dose-escalated Hypofractionated Radiotherapy For Prostate Cancer
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Canadian Association of Radiation Oncology
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40 Gy / 5 fractions / 29 days) for the treatment of low- and intermediate-risk prostate cancer.
Eligibility Criteria
Inclusion
- Men \>18 years
- Histologically confirmed prostate adenocarcinoma
- Low or low-intermediate risk prostate cancer, defined as Clinical stage T1-2b, Gleason Score \<=6, and PSA \<15 ng/mL, OR Clinical stage T1-2b, Gleason Score 7, and PSA \<=10 ng/mL
Exclusion
- Prior pelvic radiotherapy
- Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
- Diagnosis of bleeding diathesis
- Presence of a hip prosthesis
- Pelvic girth \>40cm - Large prostate (\>90cm3) on imaging
- Severe lower urinary tract symptoms (International Prostate Symptom Score \>19 or nocturia \>3)
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01146340
Start Date
May 1 2010
End Date
April 1 2016
Last Update
October 4 2019
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5