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PROFIT - Prostate Fractionated Irradiation Trial

This study has been completed.
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: July 28, 2017
Last verified: December 2016
March 17, 2006
July 28, 2017
May 2006
July 15, 2017   (Final data collection date for primary outcome measure)
Biochemical (PSA) Failure [ Time Frame: five years ]
Biochemical (PSA) Failure
Complete list of historical versions of study NCT00304759 on ClinicalTrials.gov Archive Site
  • Biochemical-Clinical Failure [ Time Frame: five years ]
  • Prostate Cancer Specific Mortality [ Time Frame: five years ]
  • Toxicity [ Time Frame: five years ]
  • Quality of Life [ Time Frame: five years ]
  • Biochemical-Clinical Failure
  • Prostate Cancer Specific Mortality
  • Toxicity
  • Quality of Life
Not Provided
Not Provided
 
PROFIT - Prostate Fractionated Irradiation Trial
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
  • Procedure: 7800 cGy/39 fractions in 8 weeks
    see above
    Other Name: standard
  • Procedure: 6000 cGy/20 fractions in 4 weeks
    see above
    Other Name: short fractionation schedule
  • Experimental: 1
    6000 cGy / 20 fractions in 4 weeks
    Intervention: Procedure: 6000 cGy/20 fractions in 4 weeks
  • Active Comparator: 2
    7800 cGy / 39 fractions in 8 weeks
    Intervention: Procedure: 7800 cGy/39 fractions in 8 weeks
Martin J, Frantzis J, Chung P, Langah I, Crain M, Cornes D, Plank A, Finch T, Jones M, Khoo E, Catton C. Prostate radiotherapy clinical trial quality assurance: how real should real time review be? (A TROG-OCOG Intergroup Project). Radiother Oncol. 2013 Jun;107(3):333-8. doi: 10.1016/j.radonc.2013.05.015. Epub 2013 Jun 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1204
July 15, 2017
July 15, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   France
 
 
NCT00304759
OCOG-2005-PROFIT
CIHR grant MCT-78776
ISRCTN43853433
Yes
Not Provided
Not Provided
Ontario Clinical Oncology Group (OCOG)
Ontario Clinical Oncology Group (OCOG)
  • Canadian Institutes of Health Research (CIHR)
  • Trans-Tasman Radiation Oncology Group (TROG)
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
Ontario Clinical Oncology Group (OCOG)
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP