External Immobilization Compared to Limited Immobilization Using a Novel Real-time Localization System of the Prostate

May 13, 2016 updated by: Dusten Macdonald, MD, U.S. Army Medical Research Acquisition Activity

This prospective study at MAMC evaluates the utility of a rigid pelvic external immobilization compared to limited immobilization using a novel real-time localization system of the prostate. The sample population will include patients referred to the radiation oncology services of both facilities for definitive treatment of prostate cancer. The study will enroll 20 subjects from MAMC and evaluate data on 860 radiation therapy fractions.

Subjects will have Beacon® Transponders implanted into the prostate to more precisely localize the position of the organ during radiation therapy. They will be randomized to rigid pelvic immobilization using a Vac-Lok® system or limited immobilization with a band around the patient's feet. They will then undergo radiation therapy planning with standard planning target margins. The Calypso® 4D Localization System will monitor, in real time, the position of the prostate target and adjust radiation treatments as required to ensure accurate treatment of the prostate gland. The time of, the number, and extent of adjustments will be recorded for analysis.

Hypothesis: 1. When treating only the prostate, treatment with rigid pelvic immobilization is not necessary when using real-time, state-of-the-art motion tracking of the prostate.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Medical application: This study will seek to determine the utility of rigid external pelvic immobilization in patients who are set up using real-time, state-of-the-art motion tracking of the prostate. External immobilization devices have been criticized for being expensive, uncomfortable, time-consuming to make, occupying a lot of space in the treatment area, creating difficulties at the time of CT simulation, challenging for obese patients and obscuring skin marks that can help confirm patient set up. Omitting these devices (if found to be unnecessary) would potentially decrease treatment costs, improve patient comfort during treatment, and reduce overall treatment time. In high risk patients, gaining a better understanding of lymph node positioning relative to Calypso immobilization may allow for decreased PTV margins and therefore decreased normal tissue irradiated during radiation therapy.

Objective(s) of the investigation: This study will look at the efficacy of external pelvic immobilization in definitive radiation therapy of prostate cancer using a unique organ tracking system.

A. Primary Objective: To determine if rigid external pelvic immobilization demonstrates a reduction in positioning errors. This will be assessed by determining the median, mean and range of shifts performed in all 3 dimensions as part of initial isocenter set-up and during treatment using the Calypso system.

B. Secondary Objectives: The study will determine the simulation time, set up time, treatment time, total time and number of treatment interventions (repositioning/pausing) caused by organ/target motion beyond planning target volume (PTV) margin using real time localization. In the subset of high-risk patients, this study will assess positioning of the lymph node target using the combination of rigid external pelvic immobilization and the Calypso system.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Tacoma, Washington, United States, 98431
        • Madigan Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

This study will include patients with prostate cancer for whom definitive radiation therapy is planned to the prostate. Patients will be referred from Urology and Radiation Oncology.

Description

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate
  • Stage T1 -T3a, N0 or NX, M0
  • Ability to comply with study schedule
  • Age 40 or older
  • Zubrod PS 0 or 1 (appendix 1)
  • Signed informed consent

Exclusion Criteria:

  • Node positive or metastatic prostate cancer
  • Prior treatment of prostate cancer with surgery, chemotherapy, cryotherapy or brachytherapy
  • History of prior pelvic radiotherapy
  • History of abdominoperineal resection
  • History of inflammatory bowel disease or connective tissue disease
  • History of HIV infection
  • History of chronic prostatitis or chronic cystitis
  • History of bleeding disorder or any active anticoagulation (excluding ASA) which cannot be safely discontinued for beacon placement
  • PT or INR outside normal range for institution
  • Active implanted devices such as cardiac pacemakers and automatic defibrillators.
  • Prosthetic implants in the pelvic region that contain metal or conductive materials (eg., an artificial hip).
  • Patients with maximum anterior-posterior separation through the torso minus the height of the center of the prostate greater than 17 cm (technical reason for Calypso System, see appendix 5).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rigid external pelvic immobilization demonstrates a reduction in positioning errors.
Time Frame: Measured at every treatment fraction for a total of approximately 8.5 weeks
This will be assessed by determining the median, mean and range of shifts performed in all 3 dimensions as part of initial isocenter set-up and during treatment using the Calypso system.
Measured at every treatment fraction for a total of approximately 8.5 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Simulation time, set up time, treatment time, total time and number of treatment interventions (repositioning/pausing) caused by organ/target motion beyond planning target volume (PTV) margin using real time localization.
Time Frame: Measured at simluation and every treatment fraction for a total of approximately 10 weeks
During each radiation treatment fraction, therapists will record these timepoints and number/duaration of treatment inverventions.
Measured at simluation and every treatment fraction for a total of approximately 10 weeks
Positioning of the lymph node target using the combination of rigid external pelvic immobilization and the Calypso system.
Time Frame: Measured at every treatment fraction for a total of approximately 8.5 weeks
This will be analyzed in the subset of high-risk patients.
Measured at every treatment fraction for a total of approximately 8.5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
U.S. Army Medical Research Acquisition Activity

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Geneva Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2009

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • W81XWH-08-2-0174, A-15214.1b
  • W81XWH-08-2-0174 (Other Grant/Funding Number: US Army Medical Research Acquisition Activity)
  • 209099 (Other Identifier: Madigan Army IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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