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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00129025
First Posted: August 11, 2005
Last Update Posted: October 10, 2011
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.
Information provided by:
AHS Cancer Control Alberta
  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
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

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
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): NCT00129025


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

ClinicalTrials.gov Identifier: NCT00129025     History of Changes
Other Study ID Numbers: GU-06-0047 / 21606
First Submitted: August 9, 2005
First Posted: August 11, 2005
Last Update Posted: October 10, 2011
Last Verified: October 2011

Keywords provided by AHS Cancer Control Alberta:
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