Shorter Radiation Schedule for the Treatment of Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00201916
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : August 17, 2010
NCIC Clinical Trials Group
Information provided by:
Ontario Clinical Oncology Group (OCOG)

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: 5250 cGy/20 fractions over 28 days Procedure: 6600 cGy/33 fractions over 45 days Phase 3

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  (Clinical Trial)
Actual Enrollment : 936 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer
Study Start Date : March 1995
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
5250 cGy in 20 fractions over 28 days
Procedure: 5250 cGy/20 fractions over 28 days
see above
Other Name: 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 Name: standard

Primary Outcome Measures :
  1. time to PSA failure [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. positive biopsy at two years post radiation [ Time Frame: see above ]
  2. disease free survival [ Time Frame: 10 years ]
  3. toxicity [ Time Frame: 10 years ]
  4. quality of life [ Time Frame: 6 years ]
  5. economic [ Time Frame: 10 years ]

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00201916

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

Publications of Results:
Responsible Party: Dr. Mark Levine, Ontario Clinical Oncology Group Identifier: NCT00201916     History of Changes
Other Study ID Numbers: OCOG-1995-PR.5
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: August 17, 2010
Last Verified: August 2010

Keywords provided by Ontario Clinical Oncology Group (OCOG):
prostate cancer
prostate specific antigen
radiation fractionation

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases