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RCT-PHART2: Trial of Hypofractionated IMRT Boost Versus Conventional IMRT Boost for Localized High Risk Prostate Cancer

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04239599
Collaborator
Sanofi (Industry)
178
Enrollment
2
Arms
153
Duration (Months)

Study Details

Study Description

Brief Summary

Hypofractionation: 48 Gy in 25 fractions to pelvic lymph nodes while the prostate receives 68 Gy in 25 fractions concomitantly.

Standard Fractionation: 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 over 39 fractions.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Hypofractionated IMRT Radiation treatment
 N/A

Detailed Description

Half the participants will receive 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).

The other half of the participants will receive 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
178 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
This is a randomized Radiation trial
Primary Purpose:
Treatment
Official Title:
Randomized Trial of Concomitant Hypofractionated IMRT Boost Versus Conventional Fractionated IMRT Boost for Localized High Risk Prostate Cancer
Study Start Date :
Mar 31, 2011
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hypofractionation

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) + 18-36 months of Eligard Hormone injection.

Radiation: Hypofractionated IMRT Radiation treatment
Other Names:
  • Eligard 22.5 mg (28.2 mg leuprolide acetate per syringe) [3-Month] for 18-36 months

    		•
    Active Comparator: Standard Fractination

    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 + 18-36 months of Eligard Hormone injection.

    Radiation: Hypofractionated IMRT Radiation treatment
    Other Names:
  • Eligard 22.5 mg (28.2 mg leuprolide acetate per syringe) [3-Month] for 18-36 months

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Disease free survival [5 years]

      The primary outcome for this study is PSA biochemical disease free survival at 5 years.

    Secondary Outcome Measures

    1. Late GI and GU toxicities [6 month post completion of treatment to end of 5 year follow up]

      Number of participants with treatment-related adverse events as assessed by CTCAE v3.0, change from 6 months post treatment to end of 5 year follow-up.

    2. Quality of life outcome: Expanded Prostate Index Composite (EPIC) [Baseline (start of treatment) to end of 5 year follow-up]

      Measuring quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.

    3. Overall survival [Baseline to end of 5 year follow-up]

      Overall survival comparing two treatment arms

    4. Cancer specific survival [Baseline to end of 5 year follow-up]

      Cancer specific survival comparing two treatment arms

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Written informed consent obtained.

    • Histologically confirmed diagnosis of adenocarcinoma of the prostate.

    • Clinical stage 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sunnybrook Health Sciences Centre
    • Sanofi

    Investigators

    • Principal Investigator: Patrick Cheung, MD, Sunnybrook Health Sciences Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sunnybrook Health Sciences Centre
    ClinicalTrials.gov Identifier:
    NCT04239599
    Other Study ID Numbers:
    • RCT- PHART2
    First Posted:
    Jan 27, 2020
    Last Update Posted:
    Jan 29, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Leuprolide

    Study Results

    No Results Posted as of Jan 29, 2020