MRI-Guided Active Selection for Treatment of Prostate Cancer: The Miami MAST Trial

University of Miami1 site in 1 country208 target enrollmentNovember 12, 2014

ConditionsProstate Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: University of Miami
Enrollment: 208
Locations: 1
Primary Endpoint: Rate of Disease Progression Within the First Two Surveillance Biopsies
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 12, 2014

End Date

May 22, 2024

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

University of Miami

Responsible Party

Principal Investigator

Sanoj Punnen, MD, MAS

Associate Professor

University of Miami

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

Outcomes

Primary Outcomes

Rate of Disease Progression Within the First Two Surveillance Biopsies

Time Frame: 24 months

The rate of disease progression among participants within the first two surveillance biopsies will be reported. Progression refers to a repeat surveillance biopsy indicating any one of the following: 1. More than 4 positive cores involving any grade of cancer, 2. At least two core with Gleason 3+4 cancer, 3. Any single core with Gleason 4+3 cancer or higher, 4. A Gleason 3+3 at diagnosis that is upgraded to Gleason 3+4, or 5. Undergoing treatment, regardless of histological progression.

Secondary Outcomes

Health-Related Quality of Life Scores: MAX-PC(Up to 36 months)
Time-to-Biochemical Recurrence (BCR)(Up to 36 months)
Health-Related Quality of Life Scores: EPIC SF-12(Up to 36 months)
Discriminative Performance of NCCN Risk and Clinical Markers for Predicting Progression on Active Surveillance(Up to 36 months)