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Shorter Radiation Schedule for the Treatment of Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
NCIC Clinical Trials Group
Information provided by:
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00201916
First received: September 13, 2005
Last updated: August 16, 2010
Last verified: August 2010
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:
  • time to PSA failure [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • positive biopsy at two years post radiation [ Time Frame: see above ] [ Designated as safety issue: No ]
  • disease free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • toxicity [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • economic [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Enrollment: 936
Study Start Date: March 1995
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201916

Locations
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
Investigators
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)
  More Information

Publications:
Responsible Party: Dr. Mark Levine, Ontario Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00201916     History of Changes
Other Study ID Numbers: OCOG-1995-PR.5, CAN-OCOG-V95-0687
Study First Received: September 13, 2005
Last Updated: August 16, 2010
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on November 27, 2014