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PROFIT - Prostate Fractionated Irradiation Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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)

Study Description
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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
Prostate Cancer 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 2006
Actual Primary Completion Date : July 15, 2017
Actual Study Completion Date : July 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Biochemical (PSA) Failure [ Time Frame: five years ]

Secondary Outcome Measures :
  1. Biochemical-Clinical Failure [ Time Frame: five years ]
  2. Prostate Cancer Specific Mortality [ Time Frame: five years ]
  3. Toxicity [ Time Frame: five years ]
  4. Quality of Life [ Time Frame: five years ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00304759


Locations
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Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Canadian Institutes of Health Research (CIHR)
Trans Tasman Radiation Oncology Group
Investigators
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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
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Publications:

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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: March 20, 2006    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: December 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:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases