Prostate Cancer
Conditions
Keywords
Prostate Cancer, Adaptive Radiotherapy, Prostatectomy, Patients who had a prostatectomy
Brief summary
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.
Interventions
RADIATIONPost-operative Adaptive Radiation Therapy
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in radiation dose delivered to target volumes and normal tissue | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time for radiotherapy replanning | 5 years | — |
| Volumetric modulated arc therapy impact in a clinical adaptive Radiotherapy workflow. | 5 years | Feasibility will be assessed by the time required to perform the adaptive intervention |
| Toxicity associated with the adaptive radiotherapy technique. | 5 years | Assessments of gastrointestinal and genitourinary complications using the Common Toxicity Criteria for Adverse Events scoring system and the Expanded Prostate Cancer Index Composite questionnaire. |
Countries
Canada
Outcome results
None listed