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PROFIT - Prostate Fractionated Irradiation Trial

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ClinicalTrials.gov Identifier: NCT00304759
Recruitment Status : Completed
First Posted : March 20, 2006
Last Update Posted : July 31, 2017
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Trans Tasman Radiation Oncology Group
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

Tracking Information
First Submitted Date  ICMJE March 17, 2006
First Posted Date  ICMJE March 20, 2006
Last Update Posted Date July 31, 2017
Study Start Date  ICMJE May 2006
Actual Primary Completion Date July 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2007)
Biochemical (PSA) Failure [ Time Frame: five years ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 17, 2006)
Biochemical (PSA) Failure
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2006)
  • Biochemical-Clinical Failure
  • Prostate Cancer Specific Mortality
  • Toxicity
  • Quality of Life
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PROFIT - Prostate Fractionated Irradiation Trial
Official Title  ICMJE A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 17, 2006)
1204
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 15, 2017
Actual Primary Completion Date July 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00304759
Other Study ID Numbers  ICMJE OCOG-2005-PROFIT
CIHR grant MCT-78776
ISRCTN43853433
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ontario Clinical Oncology Group (OCOG)
Study Sponsor  ICMJE Ontario Clinical Oncology Group (OCOG)
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • Trans Tasman Radiation Oncology Group
Investigators  ICMJE
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
PRS Account Ontario Clinical Oncology Group (OCOG)
Verification Date December 2016

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