Clinical trial NCT00754000: The AIM Study: Assessing the Impact of Margin Reduction
Official title: The AIM Study: Assessing the Impact of Margin Reduction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Varian, a Siemens Healthineers Company
Sponsor class: INDUSTRY
First posted: 2008-09-17
Enrollment: 82
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males diagnosed with prostate cancer

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate patient quality of life using Expanded Prostate Cancer Index Composite (EPIC) for evaluation of the QOL
timeFrame: 2 year follow-up
Secondary outcomes:
measure: Collection of patient tracking data from the Calypso 4D Localization System
timeFrame: 9 weeks
measure: Record the number of interventions patients receive during radiation delivery to maintain the target within the treatment plan
timeFrame: 9 weeks
measure: Evaluate the user satisfaction with the Calypso 4D Localization System
timeFrame: At time of use
measure: 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
timeFrame: 2 year follow-up
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: 21st Century Oncology - Scottsdale
state: Arizona
city: Santa Monica
country: United States
facility: 21st Century Oncology - Santa Monica
state: California
city: Cape Coral
country: United States
facility: 21st Century Oncology
state: Florida
city: Plantation
country: United States
facility: 21st Century Oncology - Plantation
state: Florida
Study officials:
affiliation: GenesisCare USA
name: Constantine Mantz, MD
role: PRINCIPAL_INVESTIGATOR
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