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

Prostate Cancer Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01588938
• Other study ID #: W81XWH-08-2-0174, A-15214.1b
• Secondary ID: W81XWH-08-2-0174
• Status: Active, not recruiting
• Phase: N/A
• First received: April 26, 2012
• Last updated: September 9, 2015
• Start date: December 2009
• Est. completion date: August 2016

Study information

• Verified date: September 2015
• Source: U.S. Army Medical Research Acquisition Activity
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: August 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer

Locations

Country	Name	City	State
United States	Madigan Healthcare System	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
U.S. Army Medical Research Acquisition Activity	The Geneva Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Measured at every treatment fraction for a total of approximately 8.5 weeks	No
Secondary	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.	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	No
Secondary	Positioning of the lymph node target using the combination of rigid external pelvic immobilization and the Calypso system.	This will be analyzed in the subset of high-risk patients.	Measured at every treatment fraction for a total of approximately 8.5 weeks	No