PROFIT - Prostate Fractionated Irradiation Trial

NCT ID: NCT00304759

Last Updated: 2017-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2017-07-15

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

6000 cGy / 20 fractions in 4 weeks

Group Type: EXPERIMENTAL

6000 cGy/20 fractions in 4 weeks

Intervention Type: PROCEDURE

see above

2

7800 cGy / 39 fractions in 8 weeks

Group Type: ACTIVE_COMPARATOR

7800 cGy/39 fractions in 8 weeks

Intervention Type: PROCEDURE

see above

Interventions

7800 cGy/39 fractions in 8 weeks

see above

Intervention Type: PROCEDURE

6000 cGy/20 fractions in 4 weeks

see above

Intervention Type: PROCEDURE

Other Intervention Names

standard; short fractionation schedule

Eligibility Criteria

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.

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Trans Tasman Radiation Oncology Group

OTHER

Sponsor Role: collaborator

Ontario Clinical Oncology Group (OCOG)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Catton, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Himu Lukka, MD

Role: PRINCIPAL_INVESTIGATOR

Juravinski Cancer Centre

Mark Levine, MD

Role: STUDY_DIRECTOR

Ontario Clinical Oncology Group (OCOG)

Jim Julian, MMATH

Role: PRINCIPAL_INVESTIGATOR

McMaster University - Department of Oncology

Locations

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

Cross Cancer Institute

Edmonton, Alberta, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, 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

Stronach Regional Cancer Centre, Southlake Regional Health Centre

Newmarket, Ontario, Canada

R.S. McLaughlin Durham Regional Cancer Centre

Oshawa, Ontario, Canada

Odette Sunnybrook Cancer Centre

Toronto, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Windsor Regional Cancer Centre

Windsor, Ontario, Canada

CHUM - Hôpital Notre-Dame

Montreal, Quebec, Canada

Montréal General Hospital

Montreal, Quebec, Canada

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Centre René Gauducheau

Nantes, Saint Herblain, France

Countries

Australia; Canada; France

References

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.

Reference Type: BACKGROUND

PMID: 23751377 (View on PubMed)

Sanmamed N, Dayes I, Catton C, Liu A, Supiot S, Lukka H, Bauman G, Liu Z, Bahary JP, Ahmed S, Cheung P, Parliament M, Sia M, Tsakiridis T, Siva S, Corbett T, Tang C, Craig T, Martin J, Chung P. Patient-reported Quality of Life in PROFIT, a Phase 3 Randomized Clinical Trial Evaluating Moderately Hypofractionated Radiotherapy for Intermediate-risk Prostate Cancer. Eur Urol Oncol. 2025 May 6:S2588-9311(25)00095-1. doi: 10.1016/j.euo.2025.03.017. Online ahead of print.

Reference Type: DERIVED

PMID: 40335398 (View on PubMed)

Other Identifiers

CIHR grant MCT-78776

Identifier Type: -

Identifier Source: secondary_id

ISRCTN43853433

Identifier Type: -

Identifier Source: secondary_id

OCOG-2005-PROFIT

Identifier Type: -

Identifier Source: org_study_id