A Phase I Trial of MRI-Guided Lattice Extreme Ablative Dose Radiotherapy For Prostate Cancer
The investigators propose to use a novel method for delivery of ablative spatially
fractionated radiation to the DCE-MRI defined tumor volume in the framework of a single-arm
phase I clinical trial. The technique, deemed Lattice Extreme Ablative Dose (LEAD) RT,
involves the creation of high doses shaped in cylinders through the DCE-MRI defined
region(s) and adjacent apparently normal prostate in a lattice framework. The LEAD RT
delivery will be in a single fraction of 12-14 Gy prior to standard fractions (2.0 Gy per
day) for an additional 76 Gy (total dose for all treatments of 88-90 Gy and 149 Gy3.0 in 2.0
Gy equivalents).
In this protocol the investigators also aim to examine biomarkers obtained from
ultrasound-guided biopsies. Emphasis will be placed on biopsying regions in which the
DCE-MRI shows enhancement. The DCE-MRI will be viewed on a separate monitor during the
ultrasound-guided biopsies to enhance the probability of obtained biomarkers more
representative of patient outcome. Biomarkers from biopsies from the index lesion(s) will be
compared to those from tumor in other areas of the prostate. Biopsy tissues will be
collected pre- and post-treatment and analyzed by immunohistochemistry (IHC) for biomarker
quantification.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Adverse Events in a Phase 1 LEAD RT Clinical Trial
To determine the number of patients with and severity of adverse events in a Phase 1 LEAD RT clinical trial.
5.25 years
Yes
Alan Pollack, MD. PhD
Principal Investigator
University of Miami Sylvester Comprehensive Cancer Center
United States: Institutional Review Board
EPROST-20100389
NCT01411319
October 2010
Name | Location |
---|---|
University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |