This trial is active, not recruiting.

Condition prostate cancer
Treatment tomotherapy
Phase phase 1/phase 2
Sponsor AHS Cancer Control Alberta
Start date April 2005
End date March 2017
Trial size 60 participants
Trial identifier NCT00126802, GU-06-0052/ethics 21781


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Rectal Toxicity
time frame: 5 weeks

Secondary Outcomes

prostate-specific antigen (PSA) and MRSI disease control
time frame: 3 years

Eligibility Criteria

Male participants up to 75 years old.

Inclusion Criteria: - High risk localized prostate cancer Exclusion Criteria: - Low/intermediate risk, metastatic cancer - Patient refusal

Additional Information

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
Principal investigator Robert Pearcey, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AHS Cancer Control Alberta.