The Miami MAST Trial

Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:35 - 85
Start Date:November 12, 2014
End Date:October 2020

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MRI-Guided Active Selection for Treatment of Prostate Cancer: The Miami MAST Trial

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

4. Genomic signatures based on RNA from tumor tissue will define patterns that are
associated with habitats and radiomics signatures, as well as progression.

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.

Inclusion Criteria:

1. Biopsy confirmed adenocarcinoma of the prostate within 18 months prior to enrollment;

2. Pre-enrollment prostate biopsy must consist of at least 8 cores;

3. Biopsy reviewed by a University of Miami Pathologist;

4. Serum Prostate-Specific Antigen (PSA) ≤ 20 ng/ml within 3 months of study enrollment;

5. Age ≥ 35 and ≤ 85 years;

6. Ability to understand and willingness to sign a written informed consent document;

7. Patients must agree to undergo serial multiparametric MRI and MRI-guided biopsy;

8. Patients must agree to fill out the longitudinal psychosocial questionnaires assessing
health related quality of life.

Exclusion Criteria:

1. Greater than 4 cores positive, of any Gleason score, on the University of Miami (UM)

2. Greater than 2 cores positive for Gleason 3+4 cancer,

3. Gleason 4+3 or higher cancer in any single biopsy core.

4. Extracapsular extension suspected on digital rectal exam with confirmation on MRI.
Suspicion of extracapsular extension on MRI alone is not an exclusion for study

5. Subject is not a candidate for multiparametric MRI with contrast. Some reasons may
include (but are not limited to): renal insufficiency, foreign body or pacemakers.

6. No prior pelvic radiotherapy.

7. No prior surgery to the prostate, other than transurethral procedures for benign
prostatic hyperplasia (e.g., transurethral resection, green light laser treatment).

8. No concurrent, active malignancy, other than non-metastatic skin cancer of any type,
superficial bladder cancer, or early stage chronic lymphocytic leukemia
(well-differentiated small cell lymphocytic lymphoma) or lymphoma. If a prior malignancy is in remission for ≥ 3 years then the patient is

9. Bilateral hip replacement.
We found this trial at
Miami, Florida 33124
(305) 284-2211
Principal Investigator: Dipen Parekh, MD
Phone: 305-243-6596
University of Miami A private research university with more than 15,000 students from around the...
Miami, FL
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