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Short-course Hypofractionated Radiotherapy for Localized Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00126165
First Posted: August 3, 2005
Last Update Posted: January 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Calgary Health Region
Information provided by:
AHS Cancer Control Alberta
August 2, 2005
August 3, 2005
January 19, 2012
September 2004
Not Provided
rectal morbidity
Same as current
Complete list of historical versions of study NCT00126165 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Short-course Hypofractionated Radiotherapy for Localized Prostate Cancer
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.
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.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
Procedure: radiotherapy
Not Provided
Wu JS, Brasher PM, El-Gayed A, Pervez N, Tai PT, Robinson J, Skarsgard D, Joseph K, Sia MA, Pearcey RG. Phase II study of hypofractionated image-guided radiotherapy for localized prostate cancer: outcomes of 55 Gy in 16 fractions at 3.4 Gy per fraction. Radiother Oncol. 2012 May;103(2):210-6. doi: 10.1016/j.radonc.2011.12.020. Epub 2012 Jan 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
August 2011
Not Provided

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00126165
17885
17885
Not Provided
Not Provided
Not Provided
Not Provided
Alberta Health Services
Calgary Health Region
Principal Investigator: Jackson Wu AHS Cancer Control Alberta
AHS Cancer Control Alberta
January 2012

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