Clinical trial NCT01505075: Safety and Efficacy Study of Hypofractionated Radiotherapy and Androgen Deprivation Therapy for Prostate Cancer
Official title: Phase II Study of Dose-escalated, Hypofractionated Radiotherapy and Androgen Deprivation Therapy for High-Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: prostatic neoplasms
radiotherapy
hypofractionated
high risk prostate cancer
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2012-01-06
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Incidence of grade 3+ rectal toxicity
timeFrame: Acute period (up to 3 months)
Secondary outcomes:
measure: Incidence of grade 3+ urinary toxicity
timeFrame: Acute (up to 3 months) and Late (after 6 months of follow-up)
measure: Quality of Life
timeFrame: 5 years
measure: Biochemical (ie.prostate specific antigen) disease free survival
timeFrame: 5 years
measure: Incidence of grade 3+ rectal toxicity
timeFrame: Late (after 6 months of follow-up)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Odette Cancer Centre, Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Andrew Loblaw, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: suneil.jain@sunnybrook.ca
name: Suneil Jain, MD
role: PRINCIPAL_INVESTIGATOR
References: