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 (NCT) | NCT00304759 |
| Protocol serial number | MCT-78776 |
| Sponsor | Ontario Clinical Oncology Group (OCOG) (Canada) |
| Funder | Canadian Institutes of Health Research (CIHR) (Canada) (ref: 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
Contact information
Dr Mark N. Levine
Scientific
Scientific
Ontario Clinical Oncology Group (OCOG)
711 Concession St
Hamilton, Ontario
L8V 1C3
Canada
| mlevine@mcmaster.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre two-arm randomised parallel trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Biochemical (PSA) relapse-free rate at 5 years post treatment. |
| Key secondary outcome measure(s) |
1. Biochemical-Clinical Failure (BCF) |
| Completion date | 30/11/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 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
L8V 1C3
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 10/06/2017 | Yes | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/03/2019: Publication reference added.
