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

NCT01588938 | Unknown DMC

• 3 other identifiers: W81XWH-08-2-0174, A-15214.1bW81XWH-08-2-0174209099
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer

Keywords

radiation therapy; Calypso

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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.

  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.

  Measured at every treatment fraction for a total of approximately 8.5 weeks

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• U.S. Army Medical Research Acquisition Activity: lead
• The Geneva Foundation: collaborator

Study Sites (1)

Madigan Healthcare System

Tacoma, Washington, 98431, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Dusten Macdonald, MD

  Department of the Army

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MC

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: May 1, 2012
• Study Start: December 1, 2009
• Primary Completion: September 1, 2016
• Study Completion: August 1, 2017
• Last Updated: May 17, 2016

Record last verified: 2016-05

Locations

US (1)