Last updated on April 2019

The Miami MAST Trial

Brief description of study

  1. Multiparametric MRI ultrasound (MRIus)-guided or direct MRI-guided biopsies will allow for more directed sampling of the tumors from compartments with distinct multiparametric-MRI (MP-MRI) characteristics, termed habitats, that will increase the rate of "progression" on early (first and second) surveillance biopsies and decrease the rate of "progression" on late (third and further) surveillance biopsies compared to historic transrectal ultrasound (TRUS)-guided biopsy rates.
  2. Identifying higher risk tumor early on will reduce the proportions of patients with poor response to delayed primary treatment.
  3. Radiomics signatures from MP-MRI will define patterns that are associated with progression.
  4. Genomic signatures based on RNA from tumor tissue will define patterns that are associated with habitats and radiomics signatures, as well as progression.

Detailed Study Description

Single arm therapeutic trial investigating the impact of MRI and MRI-US fusion biopsy to identify higher grade or volume tumors early on for better selection of patients for active surveillance and improved outcomes for those undergoing delayed treatment after initial observation.. MRI-US fusion biopsy will include targeting of suspicious areas seen on MRI as well as segmented sampling of the remaining gland. Patients will undergo MRI and MRI-US fusion biopsy within 3 months of enrollment in the trial and have repeat MRI-US fusion biopsies every year to assess overall rates and the temporal distribution of progression. Serum, urine and prostate biopsy tissue will be serially collected to investigate the association between various molecular biomarkers and radiologic and histological progression.

Clinical Study Identifier: NCT02242773

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University of Miami

Miami, FL United States
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