Safety and Efficacy Study of Hypofractionated Radiotherapy and Androgen Deprivation Therapy for Prostate Cancer
NCT ID: NCT01505075
Last Updated: 2020-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2011-09-30
2021-09-30
Brief Summary
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Detailed Description
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* 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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hypofractionated radiation
40 Gy in 5 fractions over 29 to prostate; 30 Gy in 5 fractions over 29 days to seminal vesicles
Hypofractionated radiation
40 Gy in 5 fractions to prostate, 30 Gy in 5 fractions to seminal vesicles; total treatment duration 29 days
Interventions
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Hypofractionated radiation
40 Gy in 5 fractions to prostate, 30 Gy in 5 fractions to seminal vesicles; total treatment duration 29 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Principal Investigators
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Andrew Loblaw, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Locations
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Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Countries
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Other Identifiers
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043-2011
Identifier Type: -
Identifier Source: org_study_id