PROFIT - Prostate Fractionated Irradiation Trial

July 28, 2017 updated by: Ontario Clinical Oncology Group (OCOG)

A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1204

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biochemical (PSA) Failure
Time Frame: five years
five years

Secondary Outcome Measures

Outcome Measure
Time Frame
Biochemical-Clinical Failure
Time Frame: five years
five years
Prostate Cancer Specific Mortality
Time Frame: five years
five years
Toxicity
Time Frame: five years
five years
Quality of Life
Time Frame: five years
five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

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
  • Principal Investigator: Jim Julian, MMATH, McMaster University - Department of Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

July 15, 2017

Study Completion (Actual)

July 15, 2017

Study Registration Dates

First Submitted

March 17, 2006

First Submitted That Met QC Criteria

March 17, 2006

First Posted (Estimate)

March 20, 2006

Study Record Updates

Last Update Posted (Actual)

July 31, 2017

Last Update Submitted That Met QC Criteria

July 28, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCOG-2005-PROFIT
  • CIHR grant MCT-78776
  • ISRCTN43853433

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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