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OpenTrials
Completed

NCT Number: NCT00754000

The AIM Study: Assessing the Impact of Margin Reduction

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

21st Century Oncology - Scottsdale, Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

observation

Other

AE monitoring and EPIC QOL survey

Other names: EPIC survey

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Varian, a Siemens Healthineers Company

Industry

Registry information

Acronym: AIM

Important dates

Study start
2008
Study completion
2009
First posted
Sep 17, 2008
Registry last updated
Apr 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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