The AIM Study: Assessing the Impact of Margin Reduction

Study Overview
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Brief Summary
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This study will observe patients who receive external beam radiation for prostate cancer. These patients will be localized and tracked (targeted) with the Calypso 4D Localization System. These patients will have a uniform treatment plan with reduced PTVs (prostate treatment volume) and will be assessed at multiple time points for quality of life and side effects related to radiation therapy.

Detailed Description
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EPIC surveys and adverse events recorded and categorized using the CTCAE v3.0 will be collected and summary statistics performed. The patient's individual tracking graphs will be evaluated for motion type and frequency.

Official Title
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The AIM Study: Assessing the Impact of Margin Reduction

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Observation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are planning to receive external beam radiation of prostate Patients who are to be implanted with Beacon Transponders in the prostate 18 years of age or older. Histologically confirmed diagnosis of prostate cancer. Ability to comply with study visit schedule. Signed informed consent form. Exclusion Criteria: Any patients who have received other investigational therapy within the last 60 days are excluded. Individuals that have previously been implanted with permanent Beacon transponders are excluded. Patients that have any prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip). Any other medical or other condition that would, at the discretion of the investigator, preclude the individual from participation in a clinical study.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>All patients in study | Other: Observation<br>* AE monitoring and EPIC QOL survey<br>* Other names: EPIC survey;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate patient quality of life using Expanded Prostate Cancer Index Composite (EPIC) for evaluation of the QOL |  | 2 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of patient tracking data from the Calypso 4D Localization System |  | 9 weeks | 
| Record the number of interventions patients receive during radiation delivery to maintain the target within the treatment plan |  | 9 weeks | 
| Evaluate the user satisfaction with the Calypso 4D Localization System |  | At time of use | 
| Evaluate acute and chronic (up to 2 years) toxicities of external beam prostate radiation using Common Terminology Criteria for Adverse Events for standardization of acute and chronic toxicities from the subject |  | 2 year follow-up |