- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00807820
Phase I Targeting Dominant Intraprostatic Lesion Using MR Spectroscopy and HDR Brachytherapy
Phase I Study of Targeting Dominant Intraprostatic Lesion Using Functional MR Spectroscopy and High Dose Rate 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 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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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California
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San Francisco, California, United States, 94143-1708
- University of California, San Francisco
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient must be a candidate for HDR prostate brachytherapy
- Patient must be able to have MR scan
- Patient must have a visible DIL on MRS
- Patient has signed the protocol consent form
- No prior pelvic or prostate radiation or chemotherapy for any reason
- Induction hormonal therapy beginning ≤ 120 days prior to study entry is acceptable only if there is a MRI/MRS done prior to starting hormonal therapy
- Prostate specific antigen prior to any (hormonal) therapy must be ≤ 20 ng/ml
One of the following combinations of factors:
- Clinical stage T2a-2b, Gleason score 2-6 and PSA ≥ 10 but ≤ 20
- Clinical stage T3a-T3b, Gleason score 2-6 and PSA ≤ 20
- Clinical stage T2a-T3b, Gleason score 7-10 and PSA ≤ 20
Exclusion Criteria:
- Patient with hip prosthesis
- Patient with pacemaker
- Patient with history of radical surgery for prostate
- Patient with claustrophobia
- Patient with metal in body not safe for MR
- Stage T4 disease
- Lymph node involvement (N1)
- Evidence of distant metastases (M1)
- Previous hormonal therapy beginning > 120 days prior to registration
- Hormonal therapy prior to MRI/MRS
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Estimate Grade 3 or greater genitourinary and gastrointestinal toxicity
Time Frame: One year
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MRI/MRS
Time Frame: One year
|
One year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jean Pouliot, Ph.D., Univerisity of California, San Francisco
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H11386-24294
- Grant: PC030909 (Other Grant/Funding Number: Department of Defense)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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