This trial is active, not recruiting.

Condition prostate cancer
Sponsor U.S. Army Medical Research Acquisition Activity
Collaborator The Geneva Foundation
Start date March 2009
End date May 2017
Trial size 40 participants
Trial identifier NCT01589939, 207111, W81XWH-08-2-0174, A-15214.1a


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Radiation therapy with reduced treatment margins can be adopted as feasible for routine clinical use
time frame: Approximately 8.5 weeks (43 fractions per pt.)

Secondary Outcomes

Analyze dosimetric characteristics of treatment planning
time frame: usually within the first 2 weeks after beacon placement (done at simulation CT)
Assess incidence of acute bladder and rectal toxicity
time frame: approximately 25 months (assessed prior to beacons are placed and then throughout treatment and follow-up)

Eligibility Criteria

Male participants at least 40 years old.

Inclusion Criteria: - 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 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 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.

Additional Information

Official title Reduced PTV Margins for the Treatment of Prostate Cancer With IMRT Using Real-Time, State-of-the-Art Motion Tracking With the Calypso 4D Localization System: A Feasibility Study
Principal investigator Dusten Macdonald, MD
Description This study will seek to establish the clinical feasibility of a novel real-time localization and tracking system for use of reduced PTV margins during intensity modulated radiation therapy (IMRT), which will allow treatment of smaller volumes of normal tissue during radiation therapy. Such a reduction in the PTV margins and the exposure of healthy tissue during treatment may allow for several future improvements in prostate radiotherapy including: - decreased acute and chronic adverse effects with similar local tumor control - dose escalation to achieve higher cure rates with similar adverse effects to standard dose treatment - hypofractionation to shorten the time of, and lower the expense of, treatment without increased adverse effects.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by U.S. Army Medical Research Acquisition Activity.