Prostate Cancer Clinical Trial

MRI Based Active Selection for Treatment Trial

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 require treatment earlier.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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 Bilateral hip replacement.

Study is for people with:

Prostate Cancer

Estimated Enrollment:

207

Study ID:

NCT02242773

Recruitment Status:

Active, not recruiting

Sponsor:

University of Miami

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There is 1 Location for this study

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University of Miami
Miami Florida, 33136, United States

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

207

Study ID:

NCT02242773

Recruitment Status:

Active, not recruiting

Sponsor:


University of Miami

How clear is this clinincal trial information?

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