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Shorter Radiation Schedule for the Treatment of Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
5250 cGy/20 fractions over 28 days
6600 cGy/33 fractions over 45 days
Sponsored by
Ontario Clinical Oncology Group (OCOG)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, prostate specific antigen, PSA, radiation fractionation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • B.C. Cancer Agency - Fraser Valley Cancer Centre
  • B. C. Cancer Agency - Vancouver Cancer Clinic
  • CancerCare Manitoba
  • Dr. Leon Richard Oncology Centre
  • Saint John Regional Hospital
  • Newfoundland Cancer Clinic
  • Nova Scotia Cancer Centre
  • Juravinski Cancer Centre
  • Cancer Centre of Southeastern Ontario at Kingston General Hospital
  • London Regional Cancer Centre
  • Northeastern Ontario Regional Cancer Centre
  • Thunder Bay Regional Health Sciences Centre
  • Toronto-Sunnybrook Regional Cancer Centre
  • University Health Network -Princess Margaret Hospital
  • Windsor Regional Cancer Centre
  • Saskatoon Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

5250 cGy in 20 fractions over 28 days

6600 cGy in 33 fractions over 45 days

Outcomes

Primary Outcome Measures

time to PSA failure

Secondary Outcome Measures

positive biopsy at two years post radiation
disease free survival
toxicity
quality of life
economic

Full Information

First Posted
September 13, 2005
Last Updated
August 16, 2010
Sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
NCIC Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00201916
Brief Title
Shorter Radiation Schedule for the Treatment of Prostate Cancer
Official Title
A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
March 1995 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
NCIC Clinical Trials Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, prostate specific antigen, PSA, radiation fractionation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
936 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
5250 cGy in 20 fractions over 28 days
Arm Title
2
Arm Type
Active Comparator
Arm Description
6600 cGy in 33 fractions over 45 days
Intervention Type
Procedure
Intervention Name(s)
5250 cGy/20 fractions over 28 days
Other Intervention Name(s)
short fractionation schedule
Intervention Description
see above
Intervention Type
Procedure
Intervention Name(s)
6600 cGy/33 fractions over 45 days
Other Intervention Name(s)
standard
Intervention Description
see above
Primary Outcome Measure Information:
Title
time to PSA failure
Time Frame
10 years
Secondary Outcome Measure Information:
Title
positive biopsy at two years post radiation
Time Frame
see above
Title
disease free survival
Time Frame
10 years
Title
toxicity
Time Frame
10 years
Title
quality of life
Time Frame
6 years
Title
economic
Time Frame
10 years

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Himu Lukka, MD
Organizational Affiliation
Juravinski Cancer Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Charles Hayter, MD
Organizational Affiliation
Toronto Sunnybrook Regional Cancer Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mark Levine, MD
Organizational Affiliation
Ontario Clinical Oncology Group (OCOG)
Official's Role
Principal Investigator
Facility Information:
Facility Name
B.C. Cancer Agency - Fraser Valley Cancer Centre
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
B. C. Cancer Agency - Vancouver Cancer Clinic
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Dr. Leon Richard Oncology Centre
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Newfoundland Cancer Clinic
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Nova Scotia Cancer Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Cancer Centre of Southeastern Ontario at Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Northeastern Ontario Regional Cancer Centre
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Thunder Bay Regional Health Sciences Centre
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7A 7T1
Country
Canada
Facility Name
Toronto-Sunnybrook Regional Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
University Health Network -Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Windsor Regional Cancer Centre
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 2X3
Country
Canada
Facility Name
Saskatoon Cancer Centre
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
16135479
Citation
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. doi: 10.1200/JCO.2005.06.153.
Results Reference
result

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Shorter Radiation Schedule for the Treatment of Prostate Cancer

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