- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00126165
Short-course Hypofractionated Radiotherapy for Localized Prostate Cancer
January 18, 2012 updated by: Alberta Health services
A Phase I/II Study of Escalated-dose Short-course Hypofractionated Radiotherapy (55 Gy/16 Fractions/4 Weeks) for Localized Prostate Cancer
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
72
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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rectal morbidity
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jackson Wu, AHS Cancer Control Alberta
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
August 2, 2005
First Submitted That Met QC Criteria
August 2, 2005
First Posted (Estimate)
August 3, 2005
Study Record Updates
Last Update Posted (Estimate)
January 19, 2012
Last Update Submitted That Met QC Criteria
January 18, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17885
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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