The Role of Tomotherapy in Hypofractionated/Dose Escalated Conformal Radiation Treatment for High Risk Prostate Cancer

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. Identifier: NCT00126802
Recruitment Status : Active, not recruiting
First Posted : August 5, 2005
Last Update Posted : July 6, 2016
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Brief Summary:
Helical tomotherapy is being used to treat the prostate gland, local rates of spread and regional lymph nodes whilst sparing gross structures. The radiation to the gross disease in the prostate is hypofractionated and dose escalated. Magnetic resonance spectroscopic imaging (MRSI) is incorporated into pre- and post-treatment evaluation.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Tomotherapy Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Tomotherapy (Dynamic IMRT and Megavoltage CT Scanning) in Hypofractionated/Dose Escalated Conformal Radiation Treatment Using Magnetic Resonance Spectroscopy (MRS) Scans to Predict and Document the Pattern of Local Failure for High Risk Prostate Cancer
Study Start Date : April 2005
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Intervention Details:
  • Procedure: Tomotherapy
    Standard 45 Gy in 25 fractions in 5 weeks

Primary Outcome Measures :
  1. Rectal Toxicity [ Time Frame: 5 weeks ]
    Determine the acute and late rectal toxicity of high-dose short-course hypofractionated radiotherapy in five weeks in the treatment of high rish prostate cancer.

Secondary Outcome Measures :
  1. prostate-specific antigen (PSA) and MRSI disease control [ Time Frame: 3 years ]
    Determine the biochemical control (freedom from PSA failure) rate, overall and disease free survival.

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • High risk localized prostate cancer

Exclusion Criteria:

  • Low/intermediate risk, metastatic cancer
  • 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 identifier (NCT number): NCT00126802

Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Principal Investigator: Robert Pearcey, MD AHS Cancer Control Alberta

Responsible Party: AHS Cancer Control Alberta Identifier: NCT00126802     History of Changes
Other Study ID Numbers: GU-06-0052/ethics 21781
First Posted: August 5, 2005    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016

Keywords provided by AHS Cancer Control Alberta:
high risk prostate cancer

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