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

Phase 1

• Conditions: Prostate Cancer

• Registration Number: NCT00126802
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-08-03
• Study First Submitted QC: 2005-08-03
• Study First Posted: 2005-08-05
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-04
• Last Update Posted: 2016-07-06
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• High risk localized prostate cancer

Exclusion Criteria

• Low/intermediate risk, metastatic cancer
• Patient refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
prostate-specific antigen (PSA) and MRSI disease control	3 years	Determine the biochemical control (freedom from PSA failure) rate, overall and disease free survival.

Trial Locations

Locations (1)

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada