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Prostate CancerPhase 3NCT00304759

PROFIT - Prostate Fractionated Irradiation Trial

A Phase 3 study testing 7800 cGy/39 fractions in 8 weeks and 6000 cGy/20 fractions in 4 weeks in people with Prostate Cancer, run by Ontario Clinical Oncology Group (OCOG) at 25 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Any age, men only
Conditions the study is for
Prostate Cancer
What is being tested?
7800 cGy/39 fractions in 8 weeks and 6000 cGy/20 fractions in 4 weeks
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,204 participants
Where
25 sitesin 3 countries
Study dates
May 2006to 15 Jul 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

25 sites in 3 countries.

25 sites in 3 countries

Canada15 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T4N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • The Credit Valley Hospital - Carlo Fidani Peel Regional Cancer Centre

    Mississauga, Ontario, L5M 2N1

  • CHUM - Hôpital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • Montréal General Hospital

    Montreal, Quebec, H3G 1A4

  • Stronach Regional Cancer Centre, Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9

  • R.S. McLaughlin Durham Regional Cancer Centre

    Oshawa, Ontario, L1G 2B9

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Dr. H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Odette Sunnybrook Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 1L9

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Australia9 sites

  • Ballarat Austin Radiation Oncology Centre (BAROC)

    Ballarat, Victoria, 3350

  • Liverpool Hospital & Campbelltown Hospital

    Liverpool, New South Wales, 2170

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 8006

  • Calvary Mater Newcastle Hospital

    Newcastle, New South Wales, 2310

  • Northern Sydney Cancer Centre, Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Toowoomba Cancer Research Centre

    Toowoomba, Queensland, 4350

  • Westmead Cancer Care Centre

    Wentworthville, New South Wales, 2145

  • Wollongong Hospital / Illawarra Cancer Care Centre

    Wollongong, New South Wales, 2500

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

France1 site

  • Centre René Gauducheau

    Nantes, Saint Herblain, 44093

Other trials in France

About this study

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

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.

Read the 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
Being tested
7800 cGy/39 fractions in 8 weeks, 6000 cGy/20 fractions in 4 weeks
Keywords
prostate cancer, localized prostate cancer, intermediate risk, prostate specific antigen, PSA, radiation fractionation, shorter schedule, quality of life
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 7800 cGy/39 fractions in 8 weeksProcedure or surgery

    Also called standard

    see above

  • 6000 cGy/20 fractions in 4 weeksProcedure or surgery

    Also called short fractionation schedule

    see above

Study groups in NCT00304759
Study groupRoleWhat they receive
1Experimental6000 cGy / 20 fractions in 4 weeks
Receives: Procedure: 6000 cGy/20 fractions in 4 weeks
2Active comparator7800 cGy / 39 fractions in 8 weeks
Receives: Procedure: 7800 cGy/39 fractions in 8 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemical (PSA) Failure

    Measured: five years

Secondary outcomes (4)

  1. Biochemical-Clinical Failure

    Measured: five years

  2. Prostate Cancer Specific Mortality

    Measured: five years

  3. Toxicity

    Measured: five years

  4. Quality of Life

    Measured: five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2006 (estimated)
  2. Study startMay 2006
  3. Primary completion15 Jul 2017
  4. Study completion15 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,204 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00304759
Sponsor's protocol ID
OCOG-2005-PROFIT
Other IDs
CIHR grant MCT-78776, ISRCTN43853433
Status last verified
Dec 2016
First submitted
17 Mar 2006
Last updated
31 Jul 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23751377

  • 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. 2026 Feb;9(1):26-36. doi: 10.1016/j.euo.2025.03.017. Epub 2025 May 6.

    PubMed 40335398

  • Lange M, Campion L, Ollivier L, Renouf M, Magne N, Latorzeff I, Pommier P, Martin E, Paumier A, Bera G, Catton C, Martin J, Supiot S. Patterns of Relapse Following Radiation Therapy of Intermediate-Risk Prostate Cancer in the PROFIT Randomized Trial. Int J Radiat Oncol Biol Phys. 2025 Jun 1;122(2):399-406. doi: 10.1016/j.ijrobp.2025.01.030. Epub 2025 Feb 4.

    PubMed 39914555

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 7800 cGy/39 fractions in 8 weeks and 6000 cGy/20 fractions in 4 weeks in people with Prostate Cancer, run by Ontario Clinical Oncology Group (OCOG) at 25 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Canada, Australia, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemical (PSA) Failure (time frame: five years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00304759, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2017.

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