NCT00304759

PROFIT - Prostate Fractionated Irradiation Trial

A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,204 (estimated)
• Sponsor: Ontario Clinical Oncology Group (OCOG) · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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 conventional fractionation course (7800cGy in 39 fractions over 8 weeks-standard). Three-dimensional conformal radiation treatment techniques, including intensity modulated radiotherapy will be used for both hypofractionated and standard treatments to avoid normal tissue exposure to radiation and minimize the risk of acute and late treatment related toxicity. The primary outcome measure is biochemical (PSA) failure defined by the ASTRO consensus criteria. Secondary outcomes include biochemical-clinical failure (BCF), mortality from cancer, toxicity and health-related quality of life. It is planned to recruit 1204 patients to the study. If the safety and efficacy of the shorter course are demonstrated, then its adoption would reduce the social, emotional and economic burden of treatment for patients and their families.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	7800 cGy/39 fractions in 8 weeks	see above
PROCEDURE	6000 cGy/20 fractions in 4 weeks	see above

Timeline

• Start date: 2006-05-01
• Primary completion: 2017-07-15
• Completion: 2017-07-15
• First posted: 2006-03-20
• Last updated: 2017-07-31

Locations

25 sites across 3 countries: Australia, Canada, France