Short-Course Hypofractionated Radiotherapy for Localized Prostate Cancer - Full Text View

Sponsors and Collaborators:	Alberta Cancer Board Calgary Health Region
Information provided by:	Alberta Cancer Board
ClinicalTrials.gov Identifier:	NCT00126165

Purpose

This study is aimed at providing further clinical evidence to support or refute the current understanding of biological sensitivity of prostate cancer to fractionated radiotherapy. Determining the morbidity and cancer control provided by a 4-week course of treatment will greatly influence future radiotherapy services for patients with localized prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Procedure: radiotherapy	Phase I Phase II

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I/II Study of Escalated-Dose Short-Course Hypofractionated Radiotherapy (55 Gy/16 Fractions/4 Weeks) for Localized Prostate Cancer

Further study details as provided by Alberta Cancer Board:

Primary Outcome Measures:

rectal morbidity

Estimated Enrollment:	72
Study Start Date:	September 2004

Detailed Description:

This study is aimed at providing further clinical evidence to support or refute the current understanding of biological sensitivity of prostate cancer to fractionated radiotherapy. Determining the morbidity and cancer control provided by a 4-week course of treatment will greatly influence future radiotherapy services for patients with localized prostate cancer.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Stage T1 and T2 prostate cancer
Prostate specific antigen (PSA)>=20 and Gleason score<=6
PSA<=15 and Gleason score 7
Signed informed consent

Exclusion Criteria:

No hip prosthesis, pins or screws
No previous pelvic radiotherapy
No inflammatory bowel disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126165

Contacts

Contact: Jackson Wu, MD

403-521-3095

Locations

Canada, Alberta
Tom Baker Cancer Centre	Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Rachel Syme, PhD clinical_trials_tbcc@cancerboard.ab.ca

Sponsors and Collaborators

Alberta Cancer Board

Calgary Health Region

Investigators

Principal Investigator:

Jackson Wu

Alberta Cancer Board

More Information

Study ID Numbers:	17885, 17885
Study First Received:	August 2, 2005
Last Updated:	July 12, 2006
ClinicalTrials.gov Identifier:	NCT00126165
Health Authority:	Canada: Health Canada

Keywords provided by Alberta Cancer Board:

prostate cancer
radiotherapy
hypofraction
radiosensitivity
image-guidance

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009