Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Radiosurgery

Study Overview
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Brief Summary
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Quality of life data following SBRT for prostate cancer has been obtained in only a small numbers of patients. A prospective study using validated quality of life questionnaires is needed to determine outcomes after treatment with SBRT. Our study will be the first essential step in developing a better evidence base on the comparative risks and benefits of SBRT treatment with regards to quality of life assessment and outcomes.

Detailed Description
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Study Design (for example, hypothesis, research question, standard and experimental procedures, special or unusual equipment or procedures): The main goal of this study is to evaluate quality of life outcomes and changes in patient reported symptoms (e.g. urinary, bowel and sexual function) in patients receiving SBRT treatment for clinically localized prostate cancer. Validated quality of life questionnaires will be administered in a deidentified, prospective fashion. Eligible subjects will be patients undergoing SBRT treatment for prostate cancer. Hypothesis: Patients undergoing SBRT will have similar cancer control and symptoms as men who are treated with other radiation therapy modalities. Primary objective: To evaluate quality of life outcomes (e.g. fatigue, urinary, bowel and sexual function) for patients with clinically localized prostate cancer treated with SBRT. Secondary objectives: Prospective data on cancer control and toxicity following SBRT for clinically localized prostate cancer.

Official Title
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Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Stereotactic Body Radiation Therapy (SBRT)

Conditions
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Prostate Cancer, Localized Malignant Neoplasm

Intervention / Treatment
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* Radiation: Stereotactic Body Radiation Therapy (SBRT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed adenocarcinoma of prostate Signed study-specific consent Prostate Specific Antigen (PSA) within 60 days of registration Exclusion Criteria: Prior pelvic radiotherapy Prior radical prostate surgery Medical or psychiatric illness that would interfere with treatment or follow up Implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and/or treatment delivery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| male (age > 18 y/o) with prostate cancer<br>Men received Stereotactic Body Radiation Therapy (SBRT) for clinically localized prostate cancer | Radiation: Stereotactic Body Radiation Therapy (SBRT)<br>* Stereotactic body radiation therapy for prostate<br>* Other names: CyberKnife radiosurgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fatigue | Use questionnaire to assess patient's symptoms regarding fatigue | 2 years | 
| urinary symptoms | Use questionnaire to assess patient's symptoms regarding urinary symptoms after radiosurgery | 24 months | 
| bowel symptoms | Use questionnaire to assess patient's symptoms regarding bowel symptoms after radiosurgery | 24 months | 
| sexual function | Use questionnaire to assess patient's symptoms regarding sexual symptoms after radiosurgery | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cancer control | clinical evidence of localized and distal cancer controls | 24 months | 
| toxicity symptoms | Evaluate all the treatment-related toxicity by both clinical evidence(physical exam and lab) and quality of life questionnaire | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, CyberKnife