Clinical trial NCT00304759: PROFIT - Prostate Fractionated Irradiation Trial
Official title: A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: prostate cancer
localized prostate cancer
intermediate risk
prostate specific antigen
PSA
radiation fractionation
shorter schedule
quality of life
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Trans Tasman Radiation Oncology Group
First posted: 2006-03-20
Enrollment: 1204
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Biochemical (PSA) Failure
timeFrame: five years
Secondary outcomes:
measure: Biochemical-Clinical Failure
timeFrame: five years
measure: Prostate Cancer Specific Mortality
timeFrame: five years
measure: Toxicity
timeFrame: five years
measure: Quality of Life
timeFrame: five years
Other outcomes:
Locations:
city: Liverpool
country: Australia
facility: Liverpool Hospital & Campbelltown Hospital
state: New South Wales
city: Newcastle
country: Australia
facility: Calvary Mater Newcastle Hospital
state: New South Wales
city: St. Leonards
country: Australia
facility: Northern Sydney Cancer Centre, Royal North Shore Hospital
state: New South Wales
city: Wentworthville
country: Australia
facility: Westmead Cancer Care Centre
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Hospital / Illawarra Cancer Care Centre
state: New South Wales
city: Toowoomba
country: Australia
facility: Toowoomba Cancer Research Centre
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Ballarat
country: Australia
facility: Ballarat Austin Radiation Oncology Centre (BAROC)
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: St. John's
country: Canada
facility: Dr. H. Bliss Murphy Cancer Centre
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Mississauga
country: Canada
facility: The Credit Valley Hospital - Carlo Fidani Peel Regional Cancer Centre
state: Ontario
city: Newmarket
country: Canada
facility: Stronach Regional Cancer Centre, Southlake Regional Health Centre
state: Ontario
city: Oshawa
country: Canada
facility: R.S. McLaughlin Durham Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Odette Sunnybrook Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Cancer Centre
state: Ontario
city: Montréal
country: Canada
facility: CHUM - Hôpital Notre-Dame
state: Quebec
city: Montréal
country: Canada
facility: Montréal General Hospital
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre
state: Saskatchewan
city: Nantes
country: France
facility: Centre René Gauducheau
state: Saint Herblain
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Charles Catton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Juravinski Cancer Centre
name: Himu Lukka, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ontario Clinical Oncology Group (OCOG)
name: Mark Levine, MD
role: STUDY_DIRECTOR
affiliation: McMaster University - Department of Oncology
name: Jim Julian, MMATH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.