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Hypofractionated Radiotherapy (55 Gy/16 Fractions/4 Weeks) for Localized Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00129025
First received: August 9, 2005
Last updated: October 6, 2011
Last verified: October 2011
History of Changes
  Purpose

Many patients with localized prostate cancer choose radiotherapy for treatment. Recent improvements in technology have lead to better outcomes with less side effects and better disease control rates by allowing high doses of radiation to be delivered to the cancer with lower doses to surrounding healthy tissues. Currently patients are required to attend daily treatments over seven to eight weeks which can be costly and disruptive for patients, especially those not living close to a cancer centre.

There is recent research that suggests that the same or better outcomes might be achieved in prostate cancer by delivering a smaller number of treatments, but with a higher dose of radiation given on each visit, over a shorter time than the usual seven to eight weeks.

In this study the investigators propose to treat patients with prostate cancer using 16 treatments over four weeks, thus reducing the number of visits to the cancer centre for treatment by 50%.


Condition Intervention Phase
Prostate Cancer
 Procedure: Hypofractionated 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 toxicity [ Time Frame: Study completion ]

Secondary Outcome Measures:
  • Prostate-specific antigen (PSA) control [ Time Frame: Study completion ]

Enrollment: 35
Study Start Date: October 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Low/intermediate risk localized prostate cancer

Exclusion Criteria:

  • High risk, metastatic
  • Patient refusal
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00129025

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Robert Pearcey, MD Alberta Health Services
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00129025     History of Changes
Other Study ID Numbers: GU-06-0047 / 21606
Study First Received: August 9, 2005
Last Updated: October 6, 2011
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
conformal hypofractionated radiotherapy
localized prostate cancer

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 19, 2013