PROFIT - Prostate Fractionated Irradiation Trial
This study is ongoing, but not recruiting participants.
Sponsor:
Ontario Clinical Oncology Group (OCOG)
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: January 11, 2013
Last verified: January 2013
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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:
- Histologic diagnosis of carcinoma of the prostate within 6 months of entry without evidence of metastatic disease to the lymph nodes, bone or lung;
- 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:
- Histologic diagnosis of carcinoma of the prostate more than six months prior to study entry;
- Previous therapy for carcinoma of the prostate other than biopsy or transurethral resection;
- Patients previously on more than 12 weeks of hormone therapy for treatment of their prostate cancer;
- 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;
- Treatment plan cannot meet dose constraints for the hypofractionation arm of the trial;
- Previous pelvic radiotherapy;
- Inflammatory bowel disease.
Contacts and Locations
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 | |
| CHUM - Hôpital Notre-Dame | |
| Montréal, Quebec, Canada, H2L 4M1 | |
| Montréal General Hospital | |
| Montréal, Quebec, Canada, H3G 1A4 | |
| 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: | January 11, 2013 |
| 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 Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013