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The AIM Study: Assessing the Impact of Margin Reduction


N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

The AIM Study: Assessing the Impact of Margin Reduction


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Evaluate patient quality of life using Expanded Prostate Cancer Index Composite (EPIC) for evaluation of the QOL

Outcome Time Frame:

2 year follow-up

Safety Issue:

No

Principal Investigator

Constantine Mantz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

21st Century Oncology

Authority:

United States: Institutional Review Board

Study ID:

CMT-03-08

NCT ID:

NCT00754000

Start Date:

July 2008

Completion Date:

September 2009

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

21st Century Oncology - Scottsdale Scottsdale, Arizona  85251
21st Century Oncology - Santa Monica Santa Monica, California  90404
21st Century Oncology Cape Coral, Florida  33990
21st Century Oncology - Plantation Plantation, Florida  33324