Clincosm LogoSign in Get a demo

PROFIT - Prostate Fractionated Irradiation Trial

Sponsor
Ontario Clinical Oncology Group (OCOG) (Other)
Overall Status
Completed
CT.gov ID
NCT00304759
Collaborator
Canadian Institutes of Health Research (CIHR) (Other), Trans Tasman Radiation Oncology Group (Other)
1,204
Enrollment
25
Locations
2
Arms
134.5
Duration (Months)
48.2
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is designed to determine whether an 8-week course of escalated dose conformal radiation can be compressed safely, and with similar efficacy into a 4-week course.

Condition or Disease Intervention/Treatment Phase
  • Procedure: 7800 cGy/39 fractions in 8 weeks
  • Procedure: 6000 cGy/20 fractions in 4 weeks
 Phase 3

Detailed Description

In this trial, men with intermediate risk prostate cancer will be randomized to a shorter course of radiotherapy (6000cGy in 20 fractions over 4 weeks-hypofractionated) or treatment with a conventional fractionation course (7800cGy in 39 fractions over 8 weeks-standard). Three-dimensional conformal radiation treatment techniques, including intensity modulated radiotherapy will be used for both hypofractionated and standard treatments to avoid normal tissue exposure to radiation and minimize the risk of acute and late treatment related toxicity. The primary outcome measure is biochemical (PSA) failure defined by the ASTRO consensus criteria. Secondary outcomes include biochemical-clinical failure (BCF), mortality from cancer, toxicity and health-related quality of life. It is planned to recruit 1204 patients to the study. If the safety and efficacy of the shorter course are demonstrated, then its adoption would reduce the social, emotional and economic burden of treatment for patients and their families.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1204 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer
Study Start Date :
May 1, 2006
Actual Primary Completion Date :
Jul 15, 2017
Actual Study Completion Date :
Jul 15, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

6000 cGy / 20 fractions in 4 weeks

Procedure: 6000 cGy/20 fractions in 4 weeks
see above
Other Names:
  • short fractionation schedule

    		•
    Active Comparator: 2

    7800 cGy / 39 fractions in 8 weeks

    Procedure: 7800 cGy/39 fractions in 8 weeks
    see above
    Other Names:
  • standard

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Biochemical (PSA) Failure [five years]

    Secondary Outcome Measures

    1. Biochemical-Clinical Failure [five years]

    2. Prostate Cancer Specific Mortality [five years]

    3. Toxicity [five years]

    4. Quality of Life [five years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Histologic diagnosis of carcinoma of the prostate within 6 months of entry without evidence of metastatic disease to the lymph nodes, bone or lung;

    2. Intermediate risk prostate cancer (that is, T1-2a, Gleason score <6, PSA 10.1-20.0 ng/ml; T2b-c Gleason <6, PSA ≤ 20.0 ng/ml; T1-2, Gleason 7, PSA ≤ 20.0 ng/ml).

    Exclusion Criteria:

    1. Histologic diagnosis of carcinoma of the prostate more than six months prior to study entry;

    2. Previous therapy for carcinoma of the prostate other than biopsy or transurethral resection;

    3. Patients previously on more than 12 weeks of hormone therapy for treatment of their prostate cancer;

    4. Any other active malignancy (untreated, progressive or recurrent), except for non-melanoma skin cancer. Any inactive malignancy diagnosed within 5 years of entry, except for non-melanoma skin cancer;

    5. Treatment plan cannot meet dose constraints for the hypofractionation arm of the trial;

    6. Previous pelvic radiotherapy;

    7. Inflammatory bowel disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Liverpool Hospital & Campbelltown Hospital Liverpool New South Wales Australia 2170
    2 Calvary Mater Newcastle Hospital Newcastle New South Wales Australia 2310
    3 Northern Sydney Cancer Centre, Royal North Shore Hospital St. Leonards New South Wales Australia 2065
    4 Westmead Cancer Care Centre Wentworthville New South Wales Australia 2145
    5 Wollongong Hospital / Illawarra Cancer Care Centre Wollongong New South Wales Australia 2500
    6 Toowoomba Cancer Research Centre Toowoomba Queensland Australia 4350
    7 Princess Alexandra Hospital Woolloongabba Queensland Australia 4102
    8 Ballarat Austin Radiation Oncology Centre (BAROC) Ballarat Victoria Australia 3350
    9 Peter MacCallum Cancer Centre Melbourne Victoria Australia 8006
    10 Tom Baker Cancer Centre Calgary Alberta Canada T4N 4N2
    11 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    12 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
    13 Dr. H. Bliss Murphy Cancer Centre St. John's Newfoundland and Labrador Canada A1B 3V6
    14 Juravinski Cancer Centre Hamilton Ontario Canada L8V 5C2
    15 London Regional Cancer Centre London Ontario Canada N6A 4L6
    16 The Credit Valley Hospital - Carlo Fidani Peel Regional Cancer Centre Mississauga Ontario Canada L5M 2N1
    17 Stronach Regional Cancer Centre, Southlake Regional Health Centre Newmarket Ontario Canada L3Y 2P9
    18 R.S. McLaughlin Durham Regional Cancer Centre Oshawa Ontario Canada L1G 2B9
    19 Odette Sunnybrook Cancer Centre Toronto Ontario Canada M4N 3M5
    20 Princess Margaret Hospital Toronto Ontario Canada M5G 2M9
    21 Windsor Regional Cancer Centre Windsor Ontario Canada N8W 1L9
    22 CHUM - Hôpital Notre-Dame Montréal Quebec Canada H2L 4M1
    23 Montréal General Hospital Montréal Quebec Canada H3G 1A4
    24 Allan Blair Cancer Centre Regina Saskatchewan Canada S4T 7T1
    25 Centre René Gauducheau Nantes Saint Herblain France 44093

    Sponsors and Collaborators

    • Ontario Clinical Oncology Group (OCOG)
    • Canadian Institutes of Health Research (CIHR)
    • Trans Tasman Radiation Oncology Group

    Investigators

    • Principal Investigator: Charles Catton, MD, Princess Margaret Hospital, Canada
    • Principal Investigator: Himu Lukka, MD, Juravinski Cancer Centre
    • Study Director: Mark Levine, MD, Ontario Clinical Oncology Group (OCOG)
    • Principal Investigator: Jim Julian, MMATH, McMaster University - Department of Oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ontario Clinical Oncology Group (OCOG)
    ClinicalTrials.gov Identifier:
    NCT00304759
    Other Study ID Numbers:
    • OCOG-2005-PROFIT
    • CIHR grant MCT-78776
    • ISRCTN43853433
    First Posted:
    Mar 20, 2006
    Last Update Posted:
    Jul 31, 2017
    Last Verified:
    Dec 1, 2016
    Keywords provided by Ontario Clinical Oncology Group (OCOG)
    prostate cancer
    localized prostate cancer
    intermediate risk
    prostate specific antigen
    PSA
    radiation fractionation
    shorter schedule
    quality of life
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Jul 31, 2017