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NCT00807820 · ClinicalTrials.gov registry record
Phase I Targeting Dominant Intraprostatic Lesion Using MR Spectroscopy and HDR Brachytherapy
A clinical trial, sponsored by University of California, San Francisco.
- Completed
- Registry status
- 10
- Enrollment target
NCT00807820: Completed study, sponsored by University of California, San Francisco.
NCT00807820 is a clinical trial that has completed, run by University of California, San Francisco. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00807820 has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- 10 participants
- Enrollment target
Study Summary
This is a phase I study to evaluate the feasibility and safety of using MRI/MRS to identify the dominant intraprostatic lesion (DIL) and to selectively boost the lesion using inverse planned high dose rate (HDR) brachytherapy. The main objective is to exploit the ability of MRI/MRS to identify cancer regions within the prostate or the dominant intraprostatic lesions (DIL). The imaging data will be combined with the treatment planning CT images to define a treatment plan that will boost the dose delivered to the DIL up to 150% of the prescribed dose. Dose to the whole prostate and the dose delivered to adjacent organs will not change. This is accomplished by using inverse treatment planning software that can focus normally occurring high dose regions within the target volume to coincide with the DIL. After enrollment, each patient will have a MRI/MRS before starting treatment. Hormonal therapy and external beam radiotherapy will be given based on current standard of practice. During HDR brachytherapy, information about the location of tumor within the prostate will be used to design the brachytherapy treatment plan. We will try to increase dose to DIL by coincide existing high dose region on DIL using inverse planning software. Dose to prostate, and adjacent structure will remain the same as the current treatment practice. Timing and the delivery of brachytherapy will not change from our current practice. After the treatment, each patient will remain on study and follow for 12 months and treatment toxicity will be evaluated. A two-stage study design will be applied with a stopping rule for safety. Once a patient comes off study he will be routinely followed for disease outcome and any late toxicities.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2008-03 |
| Est. Completion | 2012-01 |
What the finished NCT00807820 record still lists
NCT00807820 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00807820 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00807820 about?
NCT00807820 is a clinical study titled "Phase I Targeting Dominant Intraprostatic Lesion Using MR Spectroscopy and HDR Brachytherapy". This is a phase I study to evaluate the feasibility and safety of using MRI/MRS to identify the dominant intraprostatic lesion (DIL) and to selectively boost the lesion using inverse planned high dose rate (HDR) brachytherapy. The main objective is to exploit the ability of MRI/MRS to identify canc...
What is the current status of trial NCT00807820?
This trial is currently completed. The enrollment target is 10 participants. The study started on 2008-03. Estimated completion is 2012-01.
Who is sponsoring clinical trial NCT00807820?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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