Phase II Study of Dose-escalated, Hypofractionated Radiotherapy and Androgen Deprivation Therapy for High-Risk Prostate Cancer
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 Therapy Oncology Group (RTOG) toxicities
- Biochemical disease-free survival
- Biopsy positive rate at 3 years
- Quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
- Develop a biobank of DNA and serum extracted from blood and urine to analyze and
develop new biomarkers for prostate cancer progression or susceptibility to severe
toxicity
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of grade 3+ rectal toxicity
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Acute period (up to 3 months)
Yes
Andrew Loblaw, MD, FRCPC
Principal Investigator
Sunnybrook Health Sciences Centre
Canada: Ethics Review Committee
043-2011
NCT01505075
September 2011
September 2016
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