MRI Based Active Selection for Treatment Trial (MAST)

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Multi-Parametric MRI; Device: MRI-Guided Biopsy

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Surveillance; Participants in this group will receive a Multi-Parametric Magnetic Resonance Imaging (MP-MRI) of the prostate/pelvis and MRI-guided prostate biopsy at baseline (0-3 months from enrollment) and at the 12th, 24th and 36th month follow up.	Device: Multi-Parametric MRI; Multi-Parametric MRI; Device: MRI-Guided Biopsy; MRI-Guided Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Disease Progression Within the First Two Surveillance Biopsies	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: More than 4 positive cores involving any grade of cancer,; At least two core with Gleason 3+4 cancer,; Any single core with Gleason 4+3 cancer or higher,; A Gleason 3+3 at diagnosis that is upgraded to Gleason 3+4, or; Undergoing treatment, regardless of histological progression.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-Related Quality of Life Scores: MAX-PC	Health-Related Quality of Life will be assessed using scores from validated questionnaires. The Memorial Anxiety Scale for Prostate Cancer (MAX-PC) will be used to measure anxiety from pre-treatment to post-treatment. The scale consists of 18 items (e.g. "I thought about prostate cancer even though I didn't mean to.") scored on a scale from 0 ("not at all") to 3 ("often"). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety.	Up to 36 months
Time-to-Biochemical Recurrence (BCR)	Biochemical recurrence (BCR) is defined as prostate-specific antigen (PSA) of 0.2 or higher on two or more separate measures after surgery or an increase of nadir + 2ng/ml or more after radiation. Time-to-BCR is defined as duration in days between date of treatment and date of BCR, if BCR occurs. The investigators will follow participants who have progressed and gone on to treatment.	Up to 36 months
Health-Related Quality of Life Scores: EPIC SF-12	Health-Related Quality of Life will be assessed using scores from validated questionnaires. The Expanded Prostate Cancer Index Composite and Medical Outcomes Study Short Form-12 (EPIC SF-12) will be used to evaluate patient function and satisfaction after prostate cancer treatment. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.	Up to 36 months
Discriminative Performance of NCCN Risk and Clinical Markers for Predicting Progression on Active Surveillance	The investigators will assess the incremental benefit of multiparametric MRI (mpMRI), genomic risk test, and molecular markers compared to baseline National Comprehensive Cancer Network (NCCN) risk classification for predicting progression on active surveillance. Area under the receiver operating characteristic Curve (ROC) curves produced from logistic regression modeling will be used to evaluate the performance of NCCN risk and other variables (MRI, genomic testing, and molecular markers) for predicting progression on surveillance. Participants will be categorized at baseline by NCCN risk class ranging from very low risk to intermediate risk; and into those who progressed while on the trial. Additionally, MRI results, PSA density, 4K score, and Decipher Score in combination with NCCN risk were analyzed to see their additive value on determining who will experience progression on active surveillance.	Up to 36 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Sanoj Punnen, MD, MAS, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2014
• Primary Completion (Actual): May 22, 2024
• Study Completion (Actual): May 22, 2024

Study Registration Dates

• First Submitted: September 13, 2014
• First Submitted That Met QC Criteria: September 15, 2014
• First Posted (Estimated): September 17, 2014

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Active Surveillance; MRI-Guided Biopsy; Multi-parametric MRI; MP-MRI
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 20140372; 1R01CA189295-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No