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

Phase 1

• Conditions: Prostate Cancer
• Interventions: Radiation: Hypofractionated radiation

• Registration Number: NCT01505075
• 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 (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

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-05
• Study First Submitted QC: 2012-01-05
• Study First Posted: 2012-01-06
• Primary Completion: 2013-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-24
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypofractionated radiation	Hypofractionated radiation	40 Gy in 5 fractions over 29 to prostate; 30 Gy in 5 fractions over 29 days to seminal vesicles

Primary Outcome Measures

Name	Time	Method
Incidence of grade 3+ rectal toxicity	Acute period (up to 3 months)	Common Terminology Criteria for Adverse Events (CTCAE) v3.0

Secondary Outcome Measures

Name	Time	Method
Incidence of grade 3+ rectal toxicity	Late (after 6 months of follow-up)	Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Incidence of grade 3+ urinary toxicity	Acute (up to 3 months) and Late (after 6 months of follow-up)	Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Quality of Life	5 years	Expanded Prostate Cancer Index Composite (EPIC)
Biochemical (ie.prostate specific antigen) disease free survival	5 years

Trial Locations

Locations (1)

Odette Cancer Centre, Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada