Daily Target Guided Radiation Therapy Using the Calypso 4D Localization System in Patients Who Have Had a Prostatectomy for Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Post-prostatectomy Daily Target Guided Radiotherapy Using Real-Time, State-of-the-Art Motion Tracking With the Calypso 4D Localization System: A Feasibility Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01624623
• Other study ID #: W81XWH-08-2-0174, A-15214.3
• Secondary ID: 210016
• Status: Active, not recruiting
• Phase: N/A
• First received: June 18, 2012
• Last updated: September 9, 2015
• Start date: March 2010
• 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 study will evaluate the daily use of a unique daily organ tracking system on target localization in patients treated with radiation therapy after radical prostatectomy for prostate cancer.

Improved coverage of the target volume with radiotherapy could result in improved cancer control rates and decreased coverage of surrounding structures potentially decreasing treatment toxicity.

Description:

This prospective study evaluates the clinical utility of a novel real-time localization system of the prostate bed during adjuvant or salvage radiotherapy after radical prostatectomy. This study will also determine positioning errors using daily cone-beam computed tomography in patients set up with the Calypso 4D Localization System. Subjects will have Beacon® Transponders implanted into the prostate bed. The Calypso 4D Localization System will localize the position of the prostate bed. Cone beam CT will be used daily to measure inter-transponder distance. The Calypso system will also track the prostate bed position in real time during the entire radiation treatment. The treatments will be adjusted as required to ensure accurate treatment of the clinical target volume. The time of, the number, and extent of adjustments will be recorded for analysis.

Daily cone-beam computed tomography images will also be retrospectively analyzed to assess for adequate target coverage. The analysis will be performed retrospectively through manual 3-D registration of the cone-beam CT dataset with the treatment planning CT scan. This information will determine the margins necessary for the PTV using the Calypso 4D Localization System and potentially may allow a reduction in the PTV volumes on future studies.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the prostate initially managed with prostatectomy with a detectable PSA, positive surgical margins, or extra-prostatic extension.

• 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

• History of prior pelvic radiotherapy

• History of abdominoperineal resection

• History of inflammatory bowel disease or connective tissue disease

• History of bleeding disorder or any active anticoagulant or anti-platelet medication which cannot be discontinued safely for transponder 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).

• History of HIV infection

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	Madigan Healthcare System	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
U.S. Army Medical Research Acquisition Activity

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interfraction prostate bed motion	For each fraction, measurements from the registered CTV (clinical target volume) at the midline will be obtained to structures at 3 points to assess for the degree of motion.; Inferior (defined as 8 mm below VUA); Superior (top of seminal vesicle remnant or superior most CTV slice); Middle (defined as the slice equally distant from the inferior and superior slices above)	Approximately 7.5 weeks (36-39 fractions per pt.)	No
Primary	Intrafraction prostate bed motion	Calypso session reports measuring intrafraction motion in x,y,z axis will be recorded and analyzed.	Approximately 7.5 weeks (36-39 fractions per pt.)	No