Reduced Planning Target Volume (PTV) Margins for the Treatment of Prostate Cancer Using the Calypso 4D Localization System

Status unconfirmed

Conditions studied: Prostate Cancer

In brief

This prospective study evaluates the clinical utility of a novel real-time localization system allowing for smaller volumes of normal tissue to be included in radiation field and determines dosimetric parameters and adverse effect profiles of radiation therapy using this technology. Subjects will have beacon transponders implanted into the prostate to more precisely localize the position of the organ during radiation therapy. Hypothesis: 1. Treatment with highly targeted radiation therapy can be delivered in a daily treatment time consistent with routine clinical practice. 2. Highly targeted radiation therapy with reduced PTV margin will result in a significant decrease in rectal and bladder volume treated.

Key facts

Study ID

NCT01589939

Run by

U.S. Army Medical Research Acquisition Activity

People needed

40

Starts

2009-03-01

Expected to finish

2017-08-01

Last updated by the study team

2016-05-17

Who can join

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

You may qualify if…

• Histologically confirmed adenocarcinoma of the prostate
• Low Risk: T1a, T1b, T1c, T2a; Gleason Score less than 7, PSA less than or equal to 10
• Intermediate Risk: T2b, T2c; Gleason Score less than or equal to 7, PSA less than or equal to 15
• Ability to comply with study schedule
• Age 40 or older
• Zubrod PS 0 or 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 HIV infection
• History of chronic prostatitis or chronic cystitis
• History of bleeding disorder or any active anticoagulation (excluding ASA)
• 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 8).
• Prior history of androgen deprivation therapy has been deleted and these patients are allowed on study.

Where it is running

• Madigan Healthcare System — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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