Status:
COMPLETED
PROFIT - Prostate Fractionated Irradiation Trial
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Trans Tasman Radiation Oncology Group
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE3
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 conventiona...
Eligibility Criteria
Inclusion
- Histologic diagnosis of carcinoma of the prostate within 6 months of entry without evidence of metastatic disease to the lymph nodes, bone or lung;
- 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
- Histologic diagnosis of carcinoma of the prostate more than six months prior to study entry;
- Previous therapy for carcinoma of the prostate other than biopsy or transurethral resection;
- Patients previously on more than 12 weeks of hormone therapy for treatment of their prostate cancer;
- 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;
- Treatment plan cannot meet dose constraints for the hypofractionation arm of the trial;
- Previous pelvic radiotherapy;
- Inflammatory bowel disease.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2017
Estimated Enrollment :
1204 Patients enrolled
Trial Details
Trial ID
NCT00304759
Start Date
May 1 2006
End Date
July 15 2017
Last Update
July 31 2017
Active Locations (25)
Enter a location and click search to find clinical trials sorted by distance.
1
Liverpool Hospital & Campbelltown Hospital
Liverpool, New South Wales, Australia, 2170
2
Calvary Mater Newcastle Hospital
Newcastle, New South Wales, Australia, 2310
3
Northern Sydney Cancer Centre, Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
4
Westmead Cancer Care Centre
Wentworthville, New South Wales, Australia, 2145