Safety and Efficacy Study of Dose-escalated Hypofractionated Radiotherapy For Prostate Cancer
Phase 1
Completed
- Conditions
- Prostate Cancer
- Registration Number
- NCT01146340
- Lead Sponsor
- Sunnybrook Health Sciences Centre
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 30
Inclusion Criteria
- 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 Criteria
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Incidence of grade 3+ rectal toxicity Acute period (<3 months) Common Terminology Criteria for Adverse Events (CTCAE) v3.0
- Secondary Outcome Measures
Name Time Method Quality of Life 5 years Expanded Prostate Cancer Index Composite (EPIC)
Incidence of grade 3+ rectal toxicity Late (>6 months) Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Incidence of grade 3+ urinary toxicity Acute (<3 months) and Late (>6 months) Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Biochemical (ie. prostate specific antigen) disease free survival 5 year
Trial Locations
- Locations (1)
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre🇨🇦Toronto, Ontario, Canada