NCT01505075

Safety and Efficacy Study of Hypofractionated Radiotherapy and Androgen Deprivation Therapy for Prostate Cancer

Phase II Study of Dose-escalated, Hypofractionated Radiotherapy and Androgen Deprivation Therapy for High-Risk Prostate Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Hypofractionated radiation	40 Gy in 5 fractions to prostate, 30 Gy in 5 fractions to seminal vesicles; total treatment duration 29 days

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-01-01
• Completion: 2021-09-01
• First posted: 2012-01-06
• Last updated: 2020-11-24

Locations

1 site across 1 country: Canada