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Prostate CancerMASTNCT02242773

MRI Based Active Selection for Treatment Trial

A study testing Multi-Parametric MRI and MRI-Guided Biopsy in people with Prostate Cancer, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 35 to 85 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Multi-Parametric MRI and MRI-Guided Biopsy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
1 siteUnited States
Study dates
12 Nov 2014to 22 May 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 85 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Miami

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: 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.

Conditions
Prostate Cancer
Being tested
Multi-Parametric MRI, MRI-Guided Biopsy
Keywords
Active Surveillance, MRI-Guided Biopsy, Multi-parametric MRI, MP-MRI
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-Parametric MRIDevice

    Multi-Parametric MRI

  • MRI-Guided BiopsyDevice

    MRI-Guided Biopsy

Study groups in NCT02242773
Study groupRoleWhat they receive
Active SurveillanceExperimentalParticipants 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.
Receives: Device: Multi-Parametric MRI; Device: MRI-Guided Biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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:

    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.

    Measured: 24 months

Secondary outcomes (4)

  1. 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.

    Measured: Up to 36 months

  2. 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.

    Measured: Up to 36 months

  3. 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.

    Measured: Up to 36 months

  4. 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.

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2014 (estimated)
  2. Study start12 Nov 2014
  3. Primary completion22 May 2024
  4. Study completion22 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02242773
Sponsor's protocol ID
20140372
Other IDs
1R01CA189295-01
Acronym
MAST
Status last verified
Jun 2025
First submitted
13 Sep 2014
Last updated
11 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Sharifi SHH, Williams A, Ryan JT, Ajami T, Nativ OF, Han S, Reis IM, Soodana-Prakash N, Khandekar A, Swain S, Kryvenko ON, Stoyanova R, Pollack A, Castillo PR, Nahar B, Ritch CR, Kava B, Gonzalgo ML, Parekh DJ, Punnen S. Multiparametric MRI in prostate cancer active surveillance: results from the Miami Active Surveillance Trial (MAST) trial. BJU Int. 2026 Aug;138(2):276-284. doi: 10.1111/bju.70303. Epub 2026 May 6.

    PubMed 42089595

  • Angulo-Llanos L, Cortizas EM, Williams AD, Howell NB, Guerard T, Punnen S, Masterson TA, Kava B. Evaluating the correlation between biopsy frequency and reduced sexual function in prostate cancer patients under active surveillance: a prospective cohort study. J Sex Med. 2026 Apr 9;23(5):qdag100. doi: 10.1093/jsxmed/qdag100.

    PubMed 41985042

  • Freitas PFS, Khandekar A, Porto JG, Yu H, Williams AD, Avda Y, Malpani A, Ajami T, Mendiola DF, Soodana-Prakash N, Swain S, Gaston S, Kryvenko ON, Davicioni E, Alshalalfa M, Hao Y, Mahal B, Cortizas E, Szczotka Z, Guerard T, Kava B, Stoyanova R, Ritch CR, Nahar B, Gonzalgo ML, Pollack A, Parekh DJ, Punnen S. Can Genomic Classifiers in Biopsy Cores With Grade Group 1 Cancer Predict Higher-Grade Disease Elsewhere in the Prostate? Results From the Prospective Miami Active Surveillance Trial. J Urol. 2025 Oct;214(4):383-392. doi: 10.1097/JU.0000000000004652. Epub 2025 Jun 20.

    PubMed 40540647

  • Kimbel IM, Wallaengen V, Zacharaki EI, Breto AL, Algohary A, Carbohn S, Gaston SM, Soodana-Prakash N, Freitas PFS, Kryvenko ON, Castillo P, Abramowitz MC, Ritch CR, Nahar B, Gonzalgo ML, Parekh DJ, Pollack A, Punnen S, Stoyanova R. HRS Improves Active Surveillance for Prostate Cancer by Timely Identification of Progression. Acad Radiol. 2025 Apr;32(4):2081-2089. doi: 10.1016/j.acra.2024.11.008. Epub 2024 Dec 17.

    PubMed 39694787

Questions about this trial

What is this clinical trial studying?

A study testing Multi-Parametric MRI and MRI-Guided Biopsy in people with Prostate Cancer, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Disease Progression Within the First Two Surveillance Biopsies (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02242773, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.

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MRI Based Active Selection for Treatment Trial | AzTrials