The AIM Study: Assessing the Impact of Margin Reduction

Varian

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: Observation

Study type: Observational

Funder types: Industry

Identifiers

NCT00754000

CMT-03-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

82 participants in 1 patient group

Cohort 1

Description:

All patients in study

Treatment:

Other: Observation