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):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00126802
First received: August 3, 2005
Last updated: July 4, 2016
Last verified: July 2016

August 3, 2005
July 4, 2016
April 2005
March 2017   (final data collection date for primary outcome measure)
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.
Rectal Toxicity
Complete list of historical versions of study NCT00126802 on ClinicalTrials.gov Archive Site
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.
-PSA and MRSI disease control
Not Provided
Not Provided
 
The Role of Tomotherapy in Hypofractionated/Dose Escalated Conformal Radiation Treatment for High Risk Prostate Cancer
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
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.
Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Procedure: Tomotherapy
Standard 45 Gy in 25 fractions in 5 weeks
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
March 2017
March 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • High risk localized prostate cancer

Exclusion Criteria:

  • Low/intermediate risk, metastatic cancer
  • Patient refusal
Male
up to 75 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00126802
GU-06-0052/ethics 21781
No
Not Provided
Not Provided
AHS Cancer Control Alberta
AHS Cancer Control Alberta
Not Provided
Principal Investigator: Robert Pearcey, MD AHS Cancer Control Alberta
AHS Cancer Control Alberta
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP