Status:
UNKNOWN
Safety and Efficacy Study of Hypofractionated Radiotherapy and Androgen Deprivation Therapy for Prostate Cancer
Lead Sponsor:
Sunnybrook Health Sciences Centre
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 (40Gy/5 fractions/29 days) for the treatment of high risk prostate cancer currently being managed wi...
Detailed Description
Primary Endpoints: * Acute gastrointestinal (GI) and genitourinary (GU) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 toxicities Secondary Endpoints: * Late GI and GU Radiation Therap...
Eligibility Criteria
Inclusion
- informed consent obtained
- men \> 18 years
- histologically confirmed prostate adenocarcinoma (centrally reviewed)
- high risk prostate cancer, defined as at least one of: clinical stage T3, or gleason score 8-10, or PSA \> 20ng/mL
Exclusion
- prior pelvic radiotherapy
- anticoagulation medication (if unsafe to discontinue for gold seed insertion)
- diagnosis of bleeding diathesis
- pelvic girth \> 40cm (to ensure visibility of gold seeds on electronic portal imaging)
- large prostate (\> 90cm3) on imaging
- severe lower urinary tract symptoms (International Prostate Symptom Score \>19 or nocturia \> 3)
- No evidence of castrate resistance (defined as PSA \< 3ng/mL while testosterone is \< 0.7nmol/L). Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01505075
Start Date
September 1 2011
End Date
September 1 2021
Last Update
November 24 2020
Active Locations (1)
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1
Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5