The AIM Study: Assessing the Impact of Margin Reduction

Completed

• Conditions: Prostate Cancer
• Interventions: Other: Observation

• Registration Number: NCT00754000
• Lead Sponsor: Varian, a Siemens Healthineers Company

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-09-15
• Study First Submitted QC: 2008-09-15
• Study First Posted: 2008-09-17
• Study Completion: 2009-09
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-27
• Last Update Posted: 2012-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 82

Inclusion Criteria

1. Patients who are planning to receive external beam radiation of prostate
2. Patients who are to be implanted with Beacon Transponders in the prostate
3. 18 years of age or older.
4. Histologically confirmed diagnosis of prostate cancer.
5. Ability to comply with study visit schedule.
6. Signed informed consent form.

Exclusion Criteria

1. Any patients who have received other investigational therapy within the last 60 days are excluded.
2. Individuals that have previously been implanted with permanent Beacon transponders are excluded.
3. Patients that have any prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip).
4. Any other medical or other condition that would, at the discretion of the investigator, preclude the individual from participation in a clinical study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Observation	All patients in study

Primary Outcome Measures

Name	Time	Method
Evaluate patient quality of life using Expanded Prostate Cancer Index Composite (EPIC) for evaluation of the QOL	2 year follow-up

Secondary Outcome Measures

Name	Time	Method
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
Collection of patient tracking data from the Calypso 4D Localization System	9 weeks
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

Trial Locations

Locations (4)

21st Century Oncology - Santa Monica; 🇺🇸 Santa Monica, California, United States

21st Century Oncology - Plantation; 🇺🇸 Plantation, Florida, United States

21st Century Oncology - Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

21st Century Oncology; 🇺🇸 Cape Coral, Florida, United States