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

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ClinicalTrials.gov Identifier: NCT00129025
Recruitment Status : Completed
First Posted : August 11, 2005
Last Update Posted : October 10, 2011
Sponsor:
Information provided by:
AHS Cancer Control Alberta

Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Procedure: Hypofractionated radiotherapy Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 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 : October 2004
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

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




Primary Outcome Measures :
  1. rectal toxicity [ Time Frame: Study completion ]

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


Information from the National Library of Medicine

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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

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

ClinicalTrials.gov Identifier: NCT00129025     History of Changes
Other Study ID Numbers: GU-06-0047 / 21606
First Posted: August 11, 2005    Key Record Dates
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