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The AIM Study: Assessing the Impact of Margin Reduction (AIM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00754000
Recruitment Status : Completed
First Posted : September 17, 2008
Last Update Posted : April 30, 2012
Information provided by (Responsible Party):
Varian Medical

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.

Condition or disease Intervention/treatment
Prostate Cancer Other: Observation

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.

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Study Type : Observational
Actual Enrollment : 82 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The AIM Study: Assessing the Impact of Margin Reduction
Study Start Date : July 2008
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Cohort 1
All patients in study
Other: Observation
AE monitoring and EPIC QOL survey
Other Name: EPIC survey

Primary Outcome Measures :
  1. Evaluate patient quality of life using Expanded Prostate Cancer Index Composite (EPIC) for evaluation of the QOL [ Time Frame: 2 year follow-up ]

Secondary Outcome Measures :
  1. Collection of patient tracking data from the Calypso 4D Localization System [ Time Frame: 9 weeks ]
  2. Record the number of interventions patients receive during radiation delivery to maintain the target within the treatment plan [ Time Frame: 9 weeks ]
  3. Evaluate the user satisfaction with the Calypso 4D Localization System [ Time Frame: At time of use ]
  4. 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 [ Time Frame: 2 year follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Males diagnosed with prostate cancer

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00754000

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United States, Arizona
21st Century Oncology - Scottsdale
Scottsdale, Arizona, United States, 85251
United States, California
21st Century Oncology - Santa Monica
Santa Monica, California, United States, 90404
United States, Florida
21st Century Oncology
Cape Coral, Florida, United States, 33990
21st Century Oncology - Plantation
Plantation, Florida, United States, 33324
Sponsors and Collaborators
Varian Medical
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Principal Investigator: Constantine Mantz, MD 21st Century Oncology

Pollack A. "The Prostate" in Radiation Oncology: Rationale, Techniques and Results edited by Cox and Ang. Mosby 2003 p 630.

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Responsible Party: Varian Medical Identifier: NCT00754000     History of Changes
Other Study ID Numbers: CMT-03-08
First Posted: September 17, 2008    Key Record Dates
Last Update Posted: April 30, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases