A Study of Adaptive Radiation Therapy for Pelvic Genitourinary Cancer

Study Overview
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Brief Summary
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Radical radiation therapy for prostate cancer is a common treatment that has shown to improve clinical outcomes in a post-operative setting. However, radiation therapy after surgery poses a greater risk for bladder and rectum injury for patients with prostate or bladder cancer. For prostate cancer patients, the risk is further amplified when pelvic nodes are part of the target irradiated volume. For bladder cancer patients, the risk of injury increases when more of the bladder is part of the target volume. Using an adaptive radiation therapy approach allows for correcting any shifts in the target volume. ART approach uses images from treatment to adapt the treatment plan. This study will use Adaptive Radiation Therapy for patients who receive pelvic nodal radiotherapy for either prostate or bladder cancer. Their treatment plans will adapted using MRI scans and CBCT scans taken during their first week of radiotherapy to account for any shifts in the target volume. The purpose of this study is to evaluate the feasibility of ART approach and its and on treatment plan quality metrics for pelvic radiotherapy. Acute and late toxicities will also be evaluated. 40 participants (minimum of 10 bladder cancer patients) will be enrolled. The participants will be followed for a period of 5 years post radiation therapy, during which they will have PSA as per standard practice, along with follow-up questionnaires (EPIC for prostate cancer patients and BUSS for bladder cancer patients).

Official Title
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A Study of Adaptive Radiation Therapy for Pelvic Genitourinary Cancer

Conditions
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Prostate Cancer, Bladder Cancer

Intervention / Treatment
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* Radiation: 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: Clinical stage pT3, pT4, or pT2 with positive margin; OR, any p-stage with persistently elevated post-operative PSA > 0.05ng/mL; OR, a delayed rise in PSA post-operative Histologic diagnosis of transitional cell carcinoma of the bladder with intact bladder and: Clinical stage cT2, cT3, cT4, and N0 or N1 Exclusion Criteria: Inflammatory bowel disease or other contraindications to radiotherapy. Prior pelvic radiotherapy Previous cytotoxic chemotherapy Evidence of systemic metastases on imaging

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Adaptive Radiation Therapy<br> | Radiation: Adaptive Radiation Therapy<br>* Cone-beam CT images as well as MRI scans will be used to make any changes to the radiation treatment plan, part of the way through the treatment. Adaptation of treatment plans may allow smaller target volumes to be treated with higher doses, while minimizing the side effects to surrounding organs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosimetry | Difference in dose-volume irradiation of critical organs between original and adapted plan will be compared. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity in Patients | To determine a preliminary measure of toxicity with this technique. CTCAE toxicity data will be described for this population. | Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy | 
| Bladder Cancer Patients' Quality of Life Function | Bladder Utility Symptom Scale (BUSS) questionnaires will be scored and analyzed to determine QoL function. BUSS will be scored (1-100) as per standard criteria. Data will be analyzed as a continuous variable | Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy | 
| Prostate Cancer Patients' Quality of Life Function | Expanded Prostate Cancer Index Composite (EPIC) questionnaires will be scored and analyzed to determine QoL function. EPIC will be scored (1-100) as per standard criteria. Data will be analyzed as a continuous variable | Before Radiation Therapy, and at Month 3, Year 1, 3 & 5 after Radiation Therapy | 
| Biochemical Control in Prostate Patients | For prostate patients, patients will be considered to have biochemical failure if the PSA has risen 2ng above nadir. | PSA will be done before Radiation Therapy, and at Month 3, Year 1, 3 and 5 after Radiation Therapy | 
| Local Control in Bladder Patients | Local control will be defined by an absence of clinically locally recurrent disease | 5 years | 
| Feasibility of the use of Fiducial markers for bladder RT: quality of target delineation using fiducial markers | Feasibility will be determined by analyzing the quality of target delineation using fiducial markers in bladder cancer patients. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adaptive, Radiation Therapy