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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00126802
First received: August 3, 2005
Last updated: April 9, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Prostate Cancer
 Procedure: Tomotherapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

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: 5 weeks ] [ Designated as safety issue: Yes ]
    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:
  • prostate-specific antigen (PSA) and MRSI disease control [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Determine the biochemical control (freedom from PSA failure) rate, overall and disease free survival.


Enrollment: 60
Study Start Date: April 2005
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Tomotherapy
    Standard 45 Gy in 25 fractions in 5 weeks
  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • High risk localized prostate cancer

Exclusion Criteria:

  • Low/intermediate risk, metastatic cancer
  • Patient refusal
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126802

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

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT00126802     History of Changes
Other Study ID Numbers: GU-06-0052/ethics 21781
Study First Received: August 3, 2005
Last Updated: April 9, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
tomotherapy
MRSZ
high risk 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 June 13, 2013