Prostatectomy Adaptive Radiation Therapy (ART)

Study Overview
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Brief Summary
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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.

Official Title
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A Feasibility Study of Post-operative Adaptive Radiation Therapy for Localized Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Post-operative Adaptive Radiation Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Post-Operative adaptive radiotherapy<br>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. | Radiation: Post-operative Adaptive Radiation Therapy<br> <br> * Other names: changes that might have occurred during radiation treatment and update the treatment plan to include these changes before patient treatment is continued.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in radiation dose delivered to target volumes and normal tissue |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for radiotherapy replanning |  | 5 years | 
| Volumetric modulated arc therapy impact in a clinical adaptive Radiotherapy workflow. | Feasibility will be assessed by the time required to perform the adaptive intervention | 5 years | 
| Toxicity associated with the adaptive radiotherapy technique. | Assessments of gastrointestinal and genitourinary complications using the Common Toxicity Criteria for Adverse Events scoring system and the Expanded Prostate Cancer Index Composite questionnaire. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients who had a prostatectomy, Prostate Cancer, Adaptive Radiotherapy, Prostatectomy