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Short-course Hypofractionated Radiotherapy for Localized Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Calgary Health Region
Information provided by:
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00126165
First received: August 2, 2005
Last updated: January 18, 2012
Last verified: January 2012
History of Changes
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Escalated-dose Short-course Hypofractionated Radiotherapy (55 Gy/16 Fractions/4 Weeks) for Localized Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:
  • rectal morbidity

Estimated Enrollment: 72
Study Start Date: September 2004
Study Completion Date: August 2011
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

Locations
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Sponsors and Collaborators
Alberta Health Services
Calgary Health Region
Investigators
Principal Investigator: Jackson Wu Alberta Health Services
  More Information

No publications provided by Alberta Health Services

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00126165     History of Changes
Other Study ID Numbers: 17885, 17885
Study First Received: August 2, 2005
Last Updated: January 18, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
prostate cancer
radiotherapy
hypofraction
radiosensitivity
image-guidance

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013