PROFIT - Prostate Fractionated Irradiation Trial

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00304759
• Other study ID #: OCOG-2005-PROFIT
• Secondary ID: CIHR grant MCT-7
• Status: Completed
• Phase: Phase 3
• First received: March 17, 2006
• Last updated: July 28, 2017
• Start date: May 2006
• Est. completion date: July 15, 2017

Study information

• Verified date: December 2016
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1204
• Est. completion date: July 15, 2017
• Est. primary completion date: July 15, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• 7800 cGy/39 fractions in 8 weeks
see above
• 6000 cGy/20 fractions in 4 weeks
see above

Locations

Country	Name	City	State
Australia	Ballarat Austin Radiation Oncology Centre (BAROC)	Ballarat	Victoria
Australia	Liverpool Hospital & Campbelltown Hospital	Liverpool	New South Wales
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Calvary Mater Newcastle Hospital	Newcastle	New South Wales
Australia	Northern Sydney Cancer Centre, Royal North Shore Hospital	St. Leonards	New South Wales
Australia	Toowoomba Cancer Research Centre	Toowoomba	Queensland
Australia	Westmead Cancer Care Centre	Wentworthville	New South Wales
Australia	Wollongong Hospital / Illawarra Cancer Care Centre	Wollongong	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	London Regional Cancer Centre	London	Ontario
Canada	The Credit Valley Hospital - Carlo Fidani Peel Regional Cancer Centre	Mississauga	Ontario
Canada	CHUM - Hôpital Notre-Dame	Montréal	Quebec
Canada	Montréal General Hospital	Montréal	Quebec
Canada	Stronach Regional Cancer Centre, Southlake Regional Health Centre	Newmarket	Ontario
Canada	R.S. McLaughlin Durham Regional Cancer Centre	Oshawa	Ontario
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Dr. H. Bliss Murphy Cancer Centre	St. John's	Newfoundland and Labrador
Canada	Odette Sunnybrook Cancer Centre	Toronto	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Windsor Regional Cancer Centre	Windsor	Ontario
Canada	CancerCare Manitoba	Winnipeg	Manitoba
France	Centre René Gauducheau	Nantes	Saint Herblain

Sponsors (3)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)	Canadian Institutes of Health Research (CIHR), Trans-Tasman Radiation Oncology Group (TROG)

Countries where clinical trial is conducted

Australia,  Canada,  France, 

References & Publications (1)

Martin J, Frantzis J, Chung P, Langah I, Crain M, Cornes D, Plank A, Finch T, Jones M, Khoo E, Catton C. Prostate radiotherapy clinical trial quality assurance: how real should real time review be? (A TROG-OCOG Intergroup Project). Radiother Oncol. 2013 Jun;107(3):333-8. doi: 10.1016/j.radonc.2013.05.015. Epub 2013 Jun 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical (PSA) Failure		five years
Secondary	Biochemical-Clinical Failure		five years
Secondary	Prostate Cancer Specific Mortality		five years
Secondary	Toxicity		five years
Secondary	Quality of Life		five years