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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

Brief Summary:
Randomized trial comparing 2 external beam radiotherapy fractionation schemes in patients with localized high risk prostate cancer. Primary endpoint is acute toxicity.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Conventionally Fractionated versus Hypofractionated Boost Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Concomitant Hypofractionated IMRT Boost Versus Conventional Fractionated IMRT Boost for Localized High Risk Prostate Cancer
Actual Study Start Date : June 2011
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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.
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).
Radiation: Conventionally Fractionated versus Hypofractionated Boost



Primary Outcome Measures :
  1. Acute Toxicity [ Time Frame: within 3 months after starting radiotherapy ]
    Proportion of patients experiencing grade >=2 acute toxicity


Secondary Outcome Measures :
  1. Late Toxicity [ Time Frame: beyond 3 months of starting radiotherapy ]
    Proportion of patients experiencing grade >= 2 late toxicity

  2. Biochemical Control (Phoenix Definition) [ Time Frame: at 5 years ]
    Actuarial measure of patients failing biochemically (defined as PSA nadir + 2 ng/mL)

  3. Overall Survival [ Time Frame: at 5 years ]
    Actuarial measure of patients being alive



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526510


Contacts
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Contact: Andrea Deabreu 416-480-6100 ext 1058 andrea.deabreu@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Andrea Deabreu    416-480-6100 ext 1058    andrea.deabreu@sunnybrook.ca   
Sponsors and Collaborators
Dr. Patrick Cheung
Investigators
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Study Chair: Patrick Cheung, MD Toronto Sunnybrook Regional Cancer Centre

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Responsible Party: Dr. Patrick Cheung, Radiation Oncologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03526510     History of Changes
Other Study ID Numbers: pHART2 RCT
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Patrick Cheung, Sunnybrook Health Sciences Centre:
High Risk Prostate Cancer
Radiotherapy

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases