Phase II Study of Dose-escalated, Hypofractionated Radiotherapy and Androgen Deprivation Therapy for High-Risk Prostate Cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Sunnybrook Health Sciences Centre
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Incidence of grade 3+ rectal toxicity
- Last Updated
- 5 years ago
Overview
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 with primary androgen deprivation therapy (PADT).
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 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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Incidence of grade 3+ rectal toxicity
Time Frame: Acute period (up to 3 months)
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Secondary Outcomes
- Incidence of grade 3+ rectal toxicity(Late (after 6 months of follow-up))
- Incidence of grade 3+ urinary toxicity(Acute (up to 3 months) and Late (after 6 months of follow-up))
- Quality of Life(5 years)
- Biochemical (ie.prostate specific antigen) disease free survival(5 years)