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Safety and Efficacy Study of Hypofractionated Radiotherapy and Androgen Deprivation Therapy for Prostate Cancer (pHART8)

This study is currently recruiting participants.
Verified November 2012 by Sunnybrook Health Sciences Centre
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01505075
First received: October 5, 2011
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Prostate Cancer
 Radiation: Hypofractionated radiation
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Dose-escalated, Hypofractionated Radiotherapy and Androgen Deprivation Therapy for High-Risk Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Incidence of grade 3+ rectal toxicity [ Time Frame: Acute period (up to 3 months) ] [ Designated as safety issue: Yes ]
    Common Terminology Criteria for Adverse Events (CTCAE) v3.0


Secondary Outcome Measures:
  • Incidence of grade 3+ urinary toxicity [ Time Frame: Acute (up to 3 months) and Late (after 6 months of follow-up) ] [ Designated as safety issue: Yes ]
    Common Terminology Criteria for Adverse Events (CTCAE) v3.0

  • Quality of Life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Expanded Prostate Cancer Index Composite (EPIC)

  • Biochemical (ie.prostate specific antigen) disease free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Incidence of grade 3+ rectal toxicity [ Time Frame: Late (after 6 months of follow-up) ] [ Designated as safety issue: Yes ]
    Common Terminology Criteria for Adverse Events (CTCAE) v3.0


Estimated Enrollment: 30
Study Start Date: September 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hypofractionated radiation
40 Gy in 5 fractions over 29 to prostate; 30 Gy in 5 fractions over 29 days to seminal vesicles
 Radiation: Hypofractionated radiation
40 Gy in 5 fractions to prostate, 30 Gy in 5 fractions to seminal vesicles; total treatment duration 29 days
Other Name: RapidArc

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505075

Contacts
Contact: Andrew Loblaw, MD (416) 480-4806 andrew.loblaw@sunnybrook.ca
Contact: Suneil Jain, MD suneil.jain@sunnybrook.ca

Locations
Canada, Ontario
Odette Cancer Centre, Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Andrew Loblaw, MD         andrew.loblaw@sunnybrook.ca    
Contact: Suneil Jain, MD         suneil.jain@sunnybrook.ca    
Principal Investigator: Andrew Loblaw, MD            
Principal Investigator: Suneil Jain, MD            
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Andrew Loblaw, MD, FRCPC Sunnybrook Health Sciences Centre
Principal Investigator: Suneil Jain, MD suneil.jain@sunnybrook.ca
  More Information

No publications provided

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01505075     History of Changes
Other Study ID Numbers: 043-2011
Study First Received: October 5, 2011
Last Updated: November 6, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
prostatic neoplasms
radiotherapy
hypofractionated
high risk prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
 Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013