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Hypofractionated Boost vs Conventionally Fractionated Boost for Localized High Risk Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03526510
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Patrick Cheung, Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date  ICMJE May 3, 2018
First Posted Date  ICMJE May 16, 2018
Last Update Posted Date May 16, 2018
Actual Study Start Date  ICMJE June 2011
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2018)
Acute Toxicity [ Time Frame: within 3 months after starting radiotherapy ]
Proportion of patients experiencing grade >=2 acute toxicity
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2018)
  • Late Toxicity [ Time Frame: beyond 3 months of starting radiotherapy ]
    Proportion of patients experiencing grade >= 2 late toxicity
  • Biochemical Control (Phoenix Definition) [ Time Frame: at 5 years ]
    Actuarial measure of patients failing biochemically (defined as PSA nadir + 2 ng/mL)
  • Overall Survival [ Time Frame: at 5 years ]
    Actuarial measure of patients being alive
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 Hypofractionated Boost vs Conventionally Fractionated Boost for Localized High Risk Prostate Cancer
Official Title  ICMJE Randomized Trial of Concomitant Hypofractionated IMRT Boost Versus Conventional Fractionated IMRT Boost for Localized High Risk Prostate Cancer
Brief Summary Randomized trial comparing 2 external beam radiotherapy fractionation schemes in patients with localized high risk prostate cancer. Primary endpoint is acute toxicity.
Detailed Description

Patients enrolled onto this study will be randomized to one of the following treatment arms:

  • Standard fractionation: Using 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy.
  • Hypofractionation: Using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost).

In addition, all patients receive 1.5- 3 years of androgen deprivation therapy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Radiation: Conventionally Fractionated versus Hypofractionated Boost
Study Arms  ICMJE
  • Active Comparator: Standard Fractionation
    Using 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy.
    Intervention: Radiation: Conventionally Fractionated versus Hypofractionated Boost
  • Experimental: Hypofractionation
    Using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost).
    Intervention: Radiation: Conventionally Fractionated versus Hypofractionated Boost
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 3, 2018)
178
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written informed consent obtained.
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate.
  • T1-2 N0 M0, Gleason Score <= 7, PSA 20 - 100
  • T1-2 N0 M0, Gleason Score 8 - 10, PSA <= 100
  • T3 N0 M0, any Gleason Score, PSA <= 100

Exclusion Criteria:

  • Patients with unilateral or bilateral hip replacement.
  • Patients with active collagen vascular disease.
  • Patients with active inflammatory bowel disease.
  • Patients with previous radiotherapy to the pelvis.
  • Patients with ataxia telangiectasia.
  • Patients with nodal or distant metastases
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andrea Deabreu 416-480-6100 ext 1058 andrea.deabreu@sunnybrook.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03526510
Other Study ID Numbers  ICMJE pHART2 RCT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Patrick Cheung, Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Dr. Patrick Cheung
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Patrick Cheung, MD Toronto Sunnybrook Regional Cancer Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date May 2018

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