PROFIT - Prostate Fractionated Irradiation Trial

Phase 3

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00304759
• Lead Sponsor: Ontario Clinical Oncology Group (OCOG)

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 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.

Study Timeline

• Study First Submitted: 2006-03-17
• Study First Submitted QC: 2006-03-17
• Study First Posted: 2006-03-20
• Study Start: 2006-05
• Status Verified: 2016-12
• Primary Completion: 2017-07-15
• Study Completion: 2017-07-15
• Last Update Submitted: 2017-07-28
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1204

Inclusion Criteria

1. Histologic diagnosis of carcinoma of the prostate within 6 months of entry without evidence of metastatic disease to the lymph nodes, bone or lung;
2. 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 Criteria

1. Histologic diagnosis of carcinoma of the prostate more than six months prior to study entry;
2. Previous therapy for carcinoma of the prostate other than biopsy or transurethral resection;
3. Patients previously on more than 12 weeks of hormone therapy for treatment of their prostate cancer;
4. 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;
5. Treatment plan cannot meet dose constraints for the hypofractionation arm of the trial;
6. Previous pelvic radiotherapy;
7. Inflammatory bowel disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Biochemical (PSA) Failure	five years

Secondary Outcome Measures

Name	Time	Method
Prostate Cancer Specific Mortality	five years
Toxicity	five years
Quality of Life	five years
Biochemical-Clinical Failure	five years

Trial Locations

Locations (25)

Liverpool Hospital & Campbelltown Hospital; 🇦🇺 Liverpool, New South Wales, Australia

Calvary Mater Newcastle Hospital; 🇦🇺 Newcastle, New South Wales, Australia

Northern Sydney Cancer Centre, Royal North Shore Hospital; 🇦🇺 St. Leonards, New South Wales, Australia

Westmead Cancer Care Centre; 🇦🇺 Wentworthville, New South Wales, Australia

Wollongong Hospital / Illawarra Cancer Care Centre; 🇦🇺 Wollongong, New South Wales, Australia

Toowoomba Cancer Research Centre; 🇦🇺 Toowoomba, Queensland, Australia

Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia

Ballarat Austin Radiation Oncology Centre (BAROC); 🇦🇺 Ballarat, Victoria, Australia

Peter MacCallum Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia

Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada

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