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NCT01377753 · ClinicalTrials.gov registry record · Phase 2
MR Image Guided Therapy in Prostate Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT01377753: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01377753 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01377753, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
Background: \- One way to treat prostate cancer is to use a laser to direct extreme heat to a small area of the prostate. The heat destroys tumor cells but does not affect healthy tissue. Doctors want to see if magnetic resonance imaging (MRI) can be used to improve this treatment. MRI will be used to help locate tumor cells and guide the laser during surgery. However, MRI-guided laser therapy has not been used to treat many people with prostate cancer. More studies are needed to see whether it can destroy tumor cells permanently. Objectives: \- To test the safety and effectiveness of treating prostate tumors with laser therapy guided by magnetic resonance imaging. Eligibility: \- Men at least 18 years of age who have prostate cancer that can be seen with an MRI and has not spread to other parts of the body. Design: * Participants will be screened with a physical exam and medical history. They will also have blood tests and imaging studies, and will complete questionnaires about their health. * Participants will have the MRI-guided laser treatment in the hospital. The doctor will use the MRI to control how much energy is delivered by the laser and how much tissue is destroyed. The entire procedure usually takes from 1.5 to 3 hours. * After the treatment, participants will have a catheter put in to keep the bladder emptied. The catheter will stay in for 1 to 7 days. Drugs to prevent infection and bladder spasms will be given. Participants will leave the hospital once they are well enough to go home. * Participants will have follow-up visits 3, 6, 9, 12, 18, 24, and 36 months after the therapy. They will have physical exams, and blood and urine tests. They will also answer questionnaires. Participants will have MRI scans 6, 12, 24, and 36 months after the therapy. They will have a prostate biopsy to see if there is any tumor every 12 months for the first 2 years. Another biopsy may be done in the third year.
Interventions
- DEVICE Visualase Thermal Therapy System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2011-08-12 |
| Est. Completion | 2018-07-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01377753
The ClinicalTrials.gov registry entry for NCT01377753 describes a study currently listed as completed, categorized as Phase 2. 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 National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Visualase Thermal Therapy System is the first listed.
NCT01377753 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01377753 about?
NCT01377753 is a clinical study titled "MR Image Guided Therapy in Prostate Cancer". Background: \- One way to treat prostate cancer is to use a laser to direct extreme heat to a small area of the prostate. The heat destroys tumor cells but does not affect healthy tissue. Doctors want to see if magnetic resonance imaging (MRI) can be used to improve this treatment. MRI will be used...
What is the current status of trial NCT01377753?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2011-08-12. Estimated completion is 2018-07-31.
What interventions are being tested in trial NCT01377753?
The interventions under investigation include: Visualase Thermal Therapy System (DEVICE).
Who is sponsoring clinical trial NCT01377753?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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