Status:
COMPLETED
Phase I Targeting Dominant Intraprostatic Lesion Using MR Spectroscopy and HDR Brachytherapy
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
United States Department of Defense
Conditions:
Prostate Cancer
Eligibility:
MALE
Brief 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...
Detailed Description
1.1 The goal of radiotherapy is to deliver a high dose of radiation to the target volume while minimizing the dose to the surrounding normal tissue. Using CT based three-dimensional treatment planning...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00807820
Start Date
March 1 2008
End Date
January 1 2012
Last Update
January 24 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, San Francisco
San Francisco, California, United States, 94143-1708