Status:
COMPLETED
MRI Based Active Selection for Treatment Trial
Lead Sponsor:
University of Miami
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
35-85 years
Phase:
NA
Brief Summary
The main purpose of this study is to determine if Magnetic Resonance Imaging (MRI), along with MRI targeted biopsy of suspicious lesions, is of value in detecting patients who would be likely to requi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Greater than 4 cores positive, of any Gleason score, on the University of Miami (UM) review,
- Greater than 2 cores positive for Gleason 3+4 cancer,
- Gleason 4+3 or higher cancer in any single biopsy core.
- 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.
- 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.
- 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).
- 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.
- Bilateral hip replacement.
Key Trial Info
Start Date :
November 12 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2024
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT02242773
Start Date
November 12 2014
End Date
May 22 2024
Last Update
July 11 2025
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136