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Short-course Hypofractionated Radiotherapy for Localized Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00126165
Recruitment Status : Completed
First Posted : August 3, 2005
Last Update Posted : January 19, 2012
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Procedure: radiotherapy Phase 1 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2004
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. rectal morbidity

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 AHS Cancer Control Alberta
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00126165     History of Changes
Other Study ID Numbers: 17885
First Posted: August 3, 2005    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: January 2012

Keywords provided by AHS Cancer Control Alberta:
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