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

NCT01588938 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2016-05-17

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • The Geneva Foundation

    collaborator OTHER

  • U.S. Army Medical Research Acquisition Activity

    lead FED

Principal Investigators

  • Dusten Macdonald, MD · Department of the Army

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2016-09-30
Completion
2017-08-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01588938 on ClinicalTrials.gov