Condition category
Cancer
Date applied
05/11/2007
Date assigned
05/11/2007
Last edited
12/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ocog.ca/SMAP/Trials.aspx

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

http://www.ocog.ca

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

Publication citations

Additional files

Editorial Notes