The Role of Tomotherapy in Hypofractionated/Dose Escalated Conformal Radiation Treatment for High Risk Prostate Cancer
Sponsor
AHS Cancer Control Alberta (Other)
Overall Status
Unknown status
CT.gov ID
NCT00126802
Collaborator
(none)
60
1
143
0.4
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
60 participants
Allocation:
N/A
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
:
Apr 1, 2005
Anticipated Primary Completion Date
:
Mar 1, 2017
Anticipated Study Completion Date
:
Mar 1, 2017
Outcome Measures
Primary Outcome Measures
- Rectal Toxicity [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
- prostate-specific antigen (PSA) and MRSI disease control [3 years]
Determine the biochemical control (freedom from PSA failure) rate, overall and disease free survival.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 75 Years
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cross Cancer Institute | Edmonton | Alberta | Canada | T6G 1Z2 |
Sponsors and Collaborators
- AHS Cancer Control Alberta
Investigators
- Principal Investigator: Robert Pearcey, MD, AHS Cancer Control Alberta
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00126802
Other Study ID Numbers:
- GU-06-0052/ethics 21781
First Posted:
Aug 5, 2005
Last Update Posted:
Jul 6, 2016
Last Verified:
Jul 1, 2016
Keywords provided by AHS Cancer Control Alberta
Additional relevant MeSH terms: