MRI Based Active Selection for Treatment Trial

Prior treatment

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

Other illness

• Greater than 2 cores positive for Gleason 3+4 cancer,
• Gleason 4+3 or higher cancer in any single biopsy core.
• 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.

Age

• 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 \<stage IV follicular lymphoma. If a prior malignancy is in remission for ≥ 3 years then the patient is eligible.

Other

• Greater than 4 cores positive, of any Gleason score, on the University of Miami (UM) review,
• 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.
• Bilateral hip replacement.

• Biopsy confirmed adenocarcinoma of the prostate within 18 months prior to enrollment;
• Pre-enrollment prostate biopsy must consist of at least 8 cores;
• Biopsy reviewed by a University of Miami Pathologist;
• Serum Prostate-Specific Antigen (PSA) ≤ 20 ng/ml within 3 months of study enrollment;
• Age ≥ 35 and ≤ 85 years;
• Ability to understand and willingness to sign a written informed consent document;
• Patients must agree to undergo serial multiparametric MRI and MRI-guided biopsy;
• Patients must agree to fill out the longitudinal psychosocial questionnaires assessing health related quality of life.