Shorter Radiation Schedule for the Treatment of Prostate Cancer

August 16, 2010 updated by: Ontario Clinical Oncology Group (OCOG)

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

To improve the management of patients with early stage prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To compare the efficacy of a shorter radiation fractionation schedule to the prostate (5250 cGy/20 fractions over 28 days) with a conventional schedule (6600 cGy/33 fractions over 45 days) in men receiving radiotherapy for Stage T1a moderately or poorly differentiated, or T1b, T1c, or T2 prostate cancer. The primary outcome is local control in the prostate and secondary outcomes include toxicity, disease free survival, survival, quality of life and economics.

Study Type

Interventional

Enrollment (Actual)

936

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1Z2
        • B.C. Cancer Agency - Fraser Valley Cancer Centre
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • B. C. Cancer Agency - Vancouver Cancer Clinic
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 8X3
        • Dr. Leon Richard Oncology Centre
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Saint John Regional Hospital
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Newfoundland Cancer Clinic
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Cancer Centre
    • Ontario
      • Hamilton, Ontario, Canada
        • Juravinski Cancer Centre
      • Kingston, Ontario, Canada, K7L 5P9
        • Cancer Centre of Southeastern Ontario at Kingston General Hospital
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Centre
      • Sudbury, Ontario, Canada, P3E 5J1
        • Northeastern Ontario Regional Cancer Centre
      • Thunder Bay, Ontario, Canada, P7A 7T1
        • Thunder Bay Regional Health Sciences Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto-Sunnybrook Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network -Princess Margaret Hospital
      • Windsor, Ontario, Canada, N8W 2X3
        • Windsor Regional Cancer Centre
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • histologic diagnosis of adenocarcinoma of the prostate with no evidence of metastatic disease to the nodes, bone or lung
  • stage T1a moderately or poorly differentiated, T1b, T1c or T2 by the current UICC-TNM classification

Exclusion Criteria:

  • PSA > 40 mcg/L
  • previous therapy for carcinoma of the prostate other than biopsy or TURP, including patients previously on hormone therapy for treatment of their prostate cancer
  • prior or active malignancy other than non-melanoma skin cancer; or colon or thyroid cancer treated a minimum of five years prior to study entry and presumed cured
  • simulated volume exceeds 1000 cm3
  • previous pelvic radiotherapy
  • inflammatory bowel disease
  • serious non-malignant disease which would preclude radiotherapy or surgical biopsy
  • geographic inaccessibility for follow-up
  • psychiatric or addictive disorder which would preclude obtaining informed consent or adherence to protocol
  • unable to commence radiation therapy within 26 weeks of the date of last prostatic biopsy
  • failure to give informed consent to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
5250 cGy in 20 fractions over 28 days
Procedure: 5250 cGy/20 fractions over 28 days
see above
Other Names:
  • short fractionation schedule
ACTIVE_COMPARATOR: 2
6600 cGy in 33 fractions over 45 days
Procedure: 6600 cGy/33 fractions over 45 days
see above
Other Names:
  • standard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to PSA failure
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
positive biopsy at two years post radiation
Time Frame: see above
see above
disease free survival
Time Frame: 10 years
10 years
toxicity
Time Frame: 10 years
10 years
quality of life
Time Frame: 6 years
6 years
economic
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

NCIC Clinical Trials Group

Investigators

  • Study Chair: Himu Lukka, MD, Juravinski Cancer Centre
  • Study Chair: Charles Hayter, MD, Toronto Sunnybrook Regional Cancer Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1995

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 20, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

August 17, 2010

Last Update Submitted That Met QC Criteria

August 16, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCOG-1995-PR.5
  • CAN-OCOG-V95-0687

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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