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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

August 16, 2010

Start Date ^ICMJE

March 1995

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

time to PSA failure

Change History

Complete list of historical versions of study NCT00201916 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Shorter Radiation Schedule for the Treatment of Prostate Cancer

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

936

Completion Date

December 2009

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00201916

Other Study ID Numbers ^ICMJE

OCOG-1995-PR.5, CAN-OCOG-V95-0687

Has Data Monitoring Committee

Responsible Party

Dr. Mark Levine, Ontario Clinical Oncology Group

Study Sponsor ^ICMJE

Ontario Clinical Oncology Group (OCOG)

Collaborators ^ICMJE

NCIC Clinical Trials Group

Investigators ^ICMJE

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)

Information Provided By

Ontario Clinical Oncology Group (OCOG)

Verification Date

August 2010

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

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