The Miami MAST Trial

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)
review,

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
enrollment.

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
eligible.

9. Bilateral hip replacement.