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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01505075
Recruitment Status : Active, not recruiting
First Posted : January 6, 2012
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date  ICMJE October 5, 2011
First Posted Date  ICMJE January 6, 2012
Last Update Posted Date May 31, 2019
Actual Study Start Date  ICMJE September 2011
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2012)
Incidence of grade 3+ rectal toxicity [ Time Frame: Acute period (up to 3 months) ]
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01505075 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2012)
  • Incidence of grade 3+ urinary toxicity [ Time Frame: 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 [ Time Frame: 5 years ]
    Expanded Prostate Cancer Index Composite (EPIC)
  • Biochemical (ie.prostate specific antigen) disease free survival [ Time Frame: 5 years ]
  • Incidence of grade 3+ rectal toxicity [ Time Frame: Late (after 6 months of follow-up) ]
    Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Hypofractionated Radiotherapy and Androgen Deprivation Therapy for Prostate Cancer
Official Title  ICMJE Phase II Study of Dose-escalated, Hypofractionated Radiotherapy and Androgen Deprivation Therapy for High-Risk Prostate Cancer
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Hypofractionated radiation
40 Gy in 5 fractions over 29 to prostate; 30 Gy in 5 fractions over 29 days to seminal vesicles
Intervention: Radiation: Hypofractionated radiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 5, 2012)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01505075
Other Study ID Numbers  ICMJE 043-2011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew Loblaw, MD, FRCPC Sunnybrook Health Sciences Centre
Principal Investigator: Suneil Jain, MD suneil.jain@sunnybrook.ca
PRS Account Sunnybrook Health Sciences Centre
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP