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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Hypofractionated radiation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypofractionated radiation<br>40 Gy in 5 fractions over 29 to prostate; 30 Gy in 5 fractions over 29 days to seminal vesicles | Radiation: Hypofractionated radiation<br>* 40 Gy in 5 fractions to prostate, 30 Gy in 5 fractions to seminal vesicles; total treatment duration 29 days<br>* Other names: RapidArc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of grade 3+ rectal toxicity | Common Terminology Criteria for Adverse Events (CTCAE) v3.0 | Acute period (up to 3 months) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostatic neoplasms, radiotherapy, hypofractionated, high risk prostate cancer