PROFIT - Prostate Fractionated Irradiation Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Trans-Tasman Radiation Oncology Group (TROG)
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00304759
First received: March 17, 2006
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Prostate Cancer
Procedure: 7800 cGy/39 fractions in 8 weeks
Procedure: 6000 cGy/20 fractions in 4 weeks
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:
  • Biochemical (PSA) Failure [ Time Frame: five years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical-Clinical Failure [ Time Frame: five years ] [ Designated as safety issue: No ]
  • Prostate Cancer Specific Mortality [ Time Frame: five years ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: five years ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: five years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1204
Study Start Date: May 2006
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
6000 cGy / 20 fractions in 4 weeks
Procedure: 6000 cGy/20 fractions in 4 weeks
see above
Other Name: short fractionation schedule
Active Comparator: 2
7800 cGy / 39 fractions in 8 weeks
Procedure: 7800 cGy/39 fractions in 8 weeks
see above
Other Name: standard

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304759

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

No publications provided

Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT00304759     History of Changes
Other Study ID Numbers: OCOG-2005-PROFIT, CIHR grant MCT-78776, ISRCTN43853433
Study First Received: March 17, 2006
Last Updated: August 27, 2014
Health Authority: Canada: Health Canada

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
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014