An observational study in Prostate Cancer, sponsored by U.S. Army Medical Research Acquisition Activity. Status unknown at 1 site in United States. Open to male participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-17.
Sponsored by U.S. Army Medical Research Acquisition Activity · Observational
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.
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:
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 40 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →U.S. Army Medical Research Acquisition Activity is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with localized prostate cancer for whom definitive radiation therapy is planned to the prostate only or prostate and seminal vesicle only, without ajuvant or neoadjuvant hormornal therpy will be referred by the radiation oncololgists and urologists.
Exclusion Criteria:
Radiation therapy with reduced treatment margins can be adopted as feasible for routine clinical use
During each radiation treatment fraction, therapists will record set up time, treatment time, total time and number of treatment interventions (repositioning/pausing) as well as the duration of the intervention caused by organ/target motion beyond planning target volume (PTV) margin using real time localization and tracking.
Time frame: Approximately 8.5 weeks (43 fractions per pt.)
Analyze dosimetric characteristics of treatment planning
Standard methods vs. reduced planning target volume expansions will be analyzed: 1. Dose Volume Histogram (DVH), bladder and rectum 2. Volume receiving 77.4Gy by the prescription dose (V77.4Gy), V70Gy, and V50Gy of bladder and rectum
Time frame: usually within the first 2 weeks after beacon placement (done at simulation CT)
Assess incidence of acute bladder and rectal toxicity
toxicity is based on the RTOG/NCI CTC and EPIC quality of life survey.
Time frame: approximately 25 months (assessed prior to beacons are placed and then throughout treatment and follow-up)
This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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U.S. Army Medical Research Acquisition Activity