Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Mark N. Levine
ORCID ID
Contact details
Ontario Clinical Oncology Group (OCOG)
711 Concession St
Hamilton
Ontario
L8V 1C3
Canada
mlevine@mcmaster.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00304759
Protocol/serial number
MCT-78776
Study information
Scientific title
Acronym
PROFIT (PROstate Fractionated Irradiation Trial)
Study hypothesis
To determine whether a 4-week course of hypofractionated radiotherapy is as safe and effective as a standard 8-week course of radiotherapy for treatment of intermediate risk localised prostate cancer.
On 12/11/2008 this record was updated to include an amendment to the exclusion criteria and a change of sponsor. The initial sponsor was McMaster University (Canada) as this was where the Ontario Clinical Oncology Group (OCOG) was initially based, but this has now moved to the Henderson Research Centre. Please also note that at this time, Australia was added to the trial countries of recruitment.
Ethics approval
1. Research Ethics Board of University Health Network, Toronto, Ontario, Canada, 16/01/2006, ref: 05-849-C
2. Research Ethics Board of McMaster University, Hamilton, Ontario, Canada, 21/02/2006, ref: 06-44
Approval for the amendment to the exclusion criteria was gained by the UHN on 16/05/2008 and the Hamilton Health Sciences on 19/08/2008.
Study design
Multicentre two-arm randomised parallel trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Prostate cancer
Intervention
Conformal external beam radiotherapy.
Standard arm: 78 Gy in 39 fractions over 7.8 weeks (5 days a week)
Investigational arm: 60 Gy in 20 fractions over 4 weeks (5 days a week)
The below contact is for scientific and public queries.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Biochemical (PSA) relapse-free rate at 5 years post treatment.
Secondary outcome measures
1. Biochemical-Clinical Failure (BCF)
2. All-cause mortality
3. Prostate cancer specific mortality
4. Treatment-related toxicity
5. Health-related quality of life
6. Economic outcomes
Overall trial start date
01/11/2005
Overall trial end date
30/11/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Histologic diagnosis of carcinoma of the prostate without evidence of metastatic disease to the lymph nodes, bone or lung; within 6 months of recruitment
2. Intermediate risk prostate cancer, that is:
2.1. T1-2a, Gleason score 6, Prostate Specific Antigen [PSA] 10.1 - 20.0 ng/ml
2.2. T2b-c Gleason 6, PSA less than or equal to 20.0 ng/ml
2.3. T1-2, Gleason 7, PSA less than or equal to 20.0 ng/ml
3. Male prostate cancer patients 50 years old and above
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
1204
Participant exclusion criteria
Current exclusion criteria as of 12/08/2014:
1. Previous therapy for carcinoma of the prostate other than biopsy or transurethral resection
2. Patients previously on more than 12 weeks of hormone therapy for treatment of their prostate cancer to be excluded from study
3. Any other active malignancy (untreated, progressive or recurrent), except for non-melanoma skin cancer. Any inactive malignancy diagnosed within 5 years of study entry, except for non-melanoma skin cancer.
4. Treatment plan cannot meet dose constraints for the hypofractionation arm of the trial
5. Previous pelvic radiotherapy
6. Inflammatory bowel disease
Previous exclusion criteria:
1. Previous therapy for carcinoma of the prostate other than biopsy or transurethral resection
2. Patients previously on more than 12 weeks of hormone therapy for treatment of their prostate cancer to be excluded from study
3. Prior or active malignancy other than non-melanoma skin cancer, or colon or thyroid cancer treated a minimum of five years prior to study entry and presumed cured
4. Treatment plan cannot meet dose constraints for the hypofractionation arm of the trial
5. Previous pelvic radiotherapy
6. Inflammatory bowel disease
Recruitment start date
01/11/2005
Recruitment end date
30/11/2012
Locations
Countries of recruitment
Australia, Canada
Trial participating centre
Ontario Clinical Oncology Group (OCOG)
Hamilton, Ontario
L8V 1C3
Canada
Sponsor information
Organisation
Ontario Clinical Oncology Group (OCOG) (Canada)
Sponsor details
Henderson Research Centre
711 Concession Street
Hamilton
Ontario
L8V 1C3
Canada
+1 905 527 2299 ext 42626
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) (ref: MCT-78776)
Alternative name(s)
Instituts de Recherche en Santé du Canada, CIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Canada
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary