Clinical Trial Summary

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Phase

N/A

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Funding Agency/Sponsor

Externally Peer-Reviewed

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Disease

Prostate, Bladder, and Kidney Cancers

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Enrollment Eligibility

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.

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