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

September 13, 2005
August 16, 2010
March 1995
December 2008   (final data collection date for primary outcome measure)
time to PSA failure [ Time Frame: 10 years ] [ Designated as safety issue: No ]
time to PSA failure
Complete list of historical versions of study NCT00201916 on ClinicalTrials.gov Archive Site
  • 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 ]
  • positive biopsy at two years post radiation
  • disease free survival
  • toxicity
  • quality of life
  • economic
Not Provided
Not Provided
 
Shorter Radiation Schedule for the Treatment of Prostate Cancer
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Procedure: 5250 cGy/20 fractions over 28 days
    see above
    Other Name: short fractionation schedule
  • Procedure: 6600 cGy/33 fractions over 45 days
    see above
    Other Name: standard
  • Experimental: 1
    5250 cGy in 20 fractions over 28 days
    Intervention: Procedure: 5250 cGy/20 fractions over 28 days
  • Active Comparator: 2
    6600 cGy in 33 fractions over 45 days
    Intervention: Procedure: 6600 cGy/33 fractions over 45 days
Lukka H, Hayter C, Julian JA, Warde P, Morris WJ, Gospodarowicz M, Levine M, Sathya J, Choo R, Prichard H, Brundage M, Kwan W. Randomized trial comparing two fractionation schedules for patients with localized prostate cancer. J Clin Oncol. 2005 Sep 1;23(25):6132-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
936
December 2009
December 2008   (final data collection date for primary outcome measure)

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
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00201916
OCOG-1995-PR.5, CAN-OCOG-V95-0687
No
Dr. Mark Levine, Ontario Clinical Oncology Group
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)
Ontario Clinical Oncology Group (OCOG)
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP