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Evaluation Of Transperineal Ultrasound For Image Guidance In The Treatment Of Prostate Cancer in Men Following Prostatectomy
NCT02110667 · View on ClinicalTrials.gov ↗
Study Summary
This study is being done to find out if transperineal ultrasound (TPUS) can help define the prostate bed for radiation treatment planning and improve upon current methods of image guidance for the treatment of prostate cancer. For the patient, TPUS involves the placement of an ultrasound probe on the perineum, the skin between the scrotum and anus, while they are lying on their back in the position they will receive their treatment. Image-guidance is required for the treatment of prostate cancer because the prostate bed shifts position depending on how full the bladder and rectum are. Image-guided radiation therapy has been done at Fletcher Allen Health Care for approximately three years. Most commonly, transabdominal ultrasound images are obtained every day and compared to an ultrasound that was done on the day of treatment planning. Adjustments in radiation field position can be done on a daily basis by comparing these images. Transperineal ultrasound has never been used for image-guidance. We completed two phases of an earlier study and have developed a TPUS device and process that allow us to get clear ultrasound pictures of the prostate gland, and now we would like to explore imaging the prostate bed left after radical prostatectomy.The TPUS has three potential advantages over the transabdominal method we currently use: 1. Transabdominal ultrasound can be a challenge for some men. A full bladder helps us get clearer images, however it is difficult for some men with prostate cancer to comfortably keep a full bladder. It is also particularly difficult to get good images in larger men who have long distances from the skin surface to the prostate bed. TPUS is not dependent on a man having a full bladder and should be less dependent on the size of the man. 2. TPUS images and the planning CT images can be acquired simultaneously. This is not possible with the abdominal probe because it gets in the way of the CT machine. Simultaneous imaging eliminates the possibilit
Conditions Studied
Interventions
- DEVICE Transperineal Ultrasound
Study Locations (1)
Vermont
- Radiation Oncology, Fletcher Allen Healthcare — Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-04 |
| Est. Completion | 2016-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02110667
The ClinicalTrials.gov registry entry for NCT02110667 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Vermont Medical Center, which has 119 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention — of which Transperineal Ultrasound is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02110667 reports 1 study location spanning 1 distinct geographic area — top geographies include Vermont. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02110667 about?
NCT02110667 is a clinical study titled "Evaluation Of Transperineal Ultrasound For Image Guidance In The Treatment Of Prostate Cancer in Men Following Prostatectomy". This study is being done to find out if transperineal ultrasound (TPUS) can help define the prostate bed for radiation treatment planning and improve upon current methods of image guidance for the treatment of prostate cancer. For the patient, TPUS involves the placement of an ultrasound probe on th...
What is the current status of trial NCT02110667?
This trial is currently completed. The enrollment target is 15 participants. The study started on 2014-04. Estimated completion is 2016-12-31.
What conditions does trial NCT02110667 study?
This clinical trial studies the following conditions: Prostate Cancer, Post-Prostatectomy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02110667?
The interventions under investigation include: Transperineal Ultrasound (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02110667?
This trial is sponsored by University of Vermont Medical Center, which has 119 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02110667 being conducted?
This trial has 1 study location across Vermont. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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