Shorter Radiation Schedule for the Treatment of Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00201916
• Other study ID #: OCOG-1995-PR.5
• Secondary ID: CAN-OCOG-V95-068
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: August 16, 2010
• Start date: March 1995
• Est. completion date: December 2009

Study information

• Verified date: August 2010
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 936
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• 5250 cGy/20 fractions over 28 days
see above
• 6600 cGy/33 fractions over 45 days
see above

Locations

Country	Name	City	State
Canada	Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	Cancer Centre of Southeastern Ontario at Kingston General Hospital	Kingston	Ontario
Canada	London Regional Cancer Centre	London	Ontario
Canada	Dr. Leon Richard Oncology Centre	Moncton	New Brunswick
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	Newfoundland Cancer Clinic	St. John's	Newfoundland and Labrador
Canada	Northeastern Ontario Regional Cancer Centre	Sudbury	Ontario
Canada	B.C. Cancer Agency - Fraser Valley Cancer Centre	Surrey	British Columbia
Canada	Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario
Canada	Toronto-Sunnybrook Regional Cancer Centre	Toronto	Ontario
Canada	University Health Network -Princess Margaret Hospital	Toronto	Ontario
Canada	B. C. Cancer Agency - Vancouver Cancer Clinic	Vancouver	British Columbia
Canada	Windsor Regional Cancer Centre	Windsor	Ontario
Canada	CancerCare Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)	Canadian Cancer Trials Group

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to PSA failure		10 years	No
Secondary	positive biopsy at two years post radiation		see above	No
Secondary	disease free survival		10 years	No
Secondary	toxicity		10 years	No
Secondary	quality of life		6 years	No
Secondary	economic		10 years	No