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

Status unconfirmed

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01624623

Run by

U.S. Army Medical Research Acquisition Activity

People needed

20

Starts

2010-03-01

Expected to finish

2016-08-01

Last updated by the study team

2015-09-11

Who can join

Age: 40 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Madigan Healthcare System — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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