A randomised trial of a shorter radiation fraction schedule for the treatment of localised prostate cancer

ISRCTN	ISRCTN43853433
DOI	https://doi.org/10.1186/ISRCTN43853433
ClinicalTrials.gov number	NCT00304759
Secondary identifying numbers	MCT-78776

Submission date: 05/11/2007
Registration date: 05/11/2007
Last edited: 20/03/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Mark N. Levine
Scientific

Ontario Clinical Oncology Group (OCOG)
711 Concession St
Hamilton, Ontario
L8V 1C3
Canada

Email	mlevine@mcmaster.ca

Study information

Study design	Multicentre two-arm randomised parallel trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A randomised trial of a shorter radiation fraction schedule for the treatment of localised prostate cancer
Study acronym	PROFIT (PROstate Fractionated Irradiation Trial)
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/11/2005
Completion date	30/11/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	1204
Key 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
Key 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
Date of first enrolment	01/11/2005
Date of final enrolment	30/11/2012

Locations

Countries of recruitment

Australia
Canada

Study participating centre

Ontario Clinical Oncology Group (OCOG)

Hamilton, Ontario
L8V 1C3
Canada

Sponsor information

Ontario Clinical Oncology Group (OCOG) (Canada)
Research organisation

Henderson Research Centre
711 Concession Street
Hamilton, Ontario
L8V 1C3
Canada

Phone	+1 905 527 2299 ext 42626
Email	a@b.com
Website	http://www.ocog.ca
"ROR"	https://ror.org/003w29077

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) (ref: MCT-78776)
Government organisation / National government

Alternative name(s): Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
Location: Canada

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	10/06/2017		Yes	No

Editorial Notes

20/03/2019: Publication reference added.