Back to resultsThe Role of Tomotherapy in Hypofractionated/Dose Escalated Conformal Radiation Treatment for High Risk Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Tomotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring tomotherapy, MRSZ, high risk prostate cancer
Eligibility Criteria
Inclusion Criteria: High risk localized prostate cancer Exclusion Criteria: Low/intermediate risk, metastatic cancer Patient refusal
Sites / Locations
- Cross Cancer Institute
Outcomes
Primary Outcome Measures
Rectal Toxicity
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
Determine the biochemical control (freedom from PSA failure) rate, overall and disease free survival.
Full Information
NCT ID
NCT00126802
First Posted
August 3, 2005
Last Updated
July 4, 2016
Sponsor
AHS Cancer Control Alberta
1. Study Identification
Unique Protocol Identification Number
NCT00126802
Brief Title
The Role of Tomotherapy in Hypofractionated/Dose Escalated Conformal Radiation Treatment for High Risk Prostate Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2005 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
tomotherapy, MRSZ, high risk prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Tomotherapy
Intervention Description
Standard 45 Gy in 25 fractions in 5 weeks
Primary Outcome Measure Information:
Title
Rectal Toxicity
Description
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.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
prostate-specific antigen (PSA) and MRSI disease control
Description
Determine the biochemical control (freedom from PSA failure) rate, overall and disease free survival.
Time Frame
3 years
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
High risk localized prostate cancer
Exclusion Criteria:
Low/intermediate risk, metastatic cancer
Patient refusal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Pearcey, MD
Organizational Affiliation
AHS Cancer Control Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
The Role of Tomotherapy in Hypofractionated/Dose Escalated Conformal Radiation Treatment for High Risk Prostate Cancer
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