Clinical trial NCT02242773: MRI Based Active Selection for Treatment Trial
Official title: MRI-Guided Active Selection for Treatment of Prostate Cancer: The Miami MAST Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Active Surveillance
MRI-Guided Biopsy
Multi-parametric MRI
MP-MRI
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2014-09-17
Enrollment: 207
Sex: MALE
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 require treatment earlier.


Eligibility criteria: 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 \<stage IV follicular lymphoma. If a prior malignancy is in remission for ≥ 3 years then the patient is eligible.
9. Bilateral hip replacement.

Primary outcomes:
measure: Rate of Disease Progression within the first two surveillance biopsies
timeFrame: 24 months
Secondary outcomes:
measure: Time-to-Biochemical Recurrence
timeFrame: Up to 36 months
measure: Health-Related Quality of Life Scores: EPIC SF-12
timeFrame: Up to 36 months
measure: Health-Related Quality of Life Scores: MAX-PC
timeFrame: Up to 36 months
measure: Area under Receiver Operating Characteristic (ROC) curve
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Sanoj Punnen, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: