This trial is active, not recruiting.

Condition prostate cancer
Treatment post-operative adaptive radiation therapy
Sponsor University Health Network, Toronto
Start date July 2013
End date July 2018
Trial size 20 participants
Trial identifier NCT02034955, UHN REB 12-5318-C


This study will ultimately aim to evaluate the side effects of treatment by asking 20 subjects to receive post-operative radiotherapy for prostate cancer with the treatment plan adapted after the first week of treatment to account for changes in the target shape. These patients will be asked to complete toxicity scores and a quality of life questionnaire at the start and completion of treatment, and at 3 months 1, 2 and 5 years from the start of radiotherapy. These results will be used to determine the feasibility of the proposed approach, and obtain early estimates of improvements in uncertainty margin requirements for this population of patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
All Patients enrolled in this study will have additional scans (Cone-Beam CT, MRI) daily during their treatment. This extra imaging will help us see any changes that might have occurred during radiation treatment and update the treatment plan to include these changes before patient treatment is continued.
post-operative adaptive radiation therapy All Patients enrolled in this study will have additional scans (Cone-Beam CT,MRI) daily during their treatment. This extra imaging will help us see any

Primary Outcomes

Change in radiation dose delivered to target volumes and normal tissue
time frame: 5 years

Secondary Outcomes

Time for radiotherapy replanning
time frame: 5 years
Volumetric modulated arc therapy impact in a clinical adaptive Radiotherapy workflow.
time frame: 5 years
Toxicity associated with the adaptive radiotherapy technique.
time frame: 5 years

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Histologic diagnosis of adenocarcinoma of the prostate after radical prostatectomy AND - Clinical stage pT3, pT4, or pT2 with positive margin OR - Any p-Stage with a persistently elevated post-operative PSA > 0.05 ng/ml OR - A delayed rise in PSA post-operatively Exclusion Criteria: - Inflammatory bowel disease or other contraindications to radiotherapy - Prior pelvic radiotherapy - Previous cytotoxic chemotherapy - Radiological or pathologic evidence of nodal metastases. - Planned radiotherapy to pelvic lymph nodes - Evidence of systemic metastases on imaging. - Prosthetic hip replacement - No signed informed consent

Additional Information

Official title A Feasibility Study of Post-operative Adaptive Radiation Therapy for Localized Prostate Cancer
Principal investigator Charles N Catton, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.