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MRI Based Active Selection for Treatment Trial (MAST)

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ClinicalTrials.gov Identifier: NCT02242773
Recruitment Status : Active, not recruiting
First Posted : September 17, 2014
Last Update Posted : March 12, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sanoj Punnen, MD, MAS, University of Miami

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Multi-Parametric MRI Device: MRI-Guided Biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MRI-Guided Active Selection for Treatment of Prostate Cancer: The Miami MAST Trial
Actual Study Start Date : November 12, 2014
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Rate of Disease Progression within the first two surveillance biopsies [ Time Frame: 24 months ]

    To determine if multiparametric MRI and MRI-US fusion biopsies increase the rate of progression (conversion to treatment) within the first two non-diagnostic biopsies after undergoing active surveillance as compared to historical cohorts using standard ultrasound guided biopsies.

    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 Outcome Measures :
  1. Molecular characterization of tissue from the multiparametric habitat-directed prostate biopsies and development of genomic signatures of indolent versus aggressive prostate cancer. [ Time Frame: 36 months ]

    Molecular characterization of tissue from the multiparametric habitat-directed prostate biopsies and development of genomic signatures of indolent versus aggressive prostate cancer using a 1.4 million feature oligonucleotide microarray capable of global high throughput analysis of formalin fixed paraffin embedded specimens.

    Aggressive cancer will be those that progress on the trial and indolent would be those who do not. The investigators will use the genomic information collected from tissue biopsies to develop a signature that is associated with progression. Outcome would be progression or no progression on trial.


  2. Identification of whether earlier identification of progression with MRI and MRI-US fusion biopsy will portend improved outcomes of patients undergoing delayed primary surgery or radiation after initial surveillance at the University of Miami. [ Time Frame: 36 months ]
    The investigators will follow participants who have progressed and gone on to treatment. The investigators will use recurrence after primary therapy as the outcome in those who progress and compare this to established literature in the field.

  3. Definition of Radiomic Signatures on multiparametric MRI that select regions of the prostate that are likely to harbor more aggressive disease. [ Time Frame: 36 months ]
    Proportion of participants who progress on study versus those who do not. Participants who progress on the study would be considered aggressive compared to those who do not. The investigators will try and identify radiomic features on the MRI that predicted progression.

  4. Health-Related Quality of Life Scores: EPIC SF-12 [ Time Frame: Up to 36 months ]
    Health-related Quality of Life (HRQOL) will be measured using the Expanded Prostate Cancer Index Composite and Medical Outcomes Study SF-12 (EPIC SF-12) 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.

  5. Health-Related Quality of Life Scores: MAX-PC [ Time Frame: Up to 36 months ]
    Health-related quality of life (HRQOL) will be measured using the scores on the Modified 18-item Memorial Anxiety Scale for Prostate Cancer (MAX-PC) 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.

  6. Relation of Radiomics and Genomics Signatures to Existing Urine, Serum and Tissue Biomarkers Associated with Prostate Cancer Diagnosis and/or Progression. [ Time Frame: Up to 36 months ]
    The investigators will look at associations between radiomic and genomic signatures to existing urinary, serum and tissue biomarkers that are associated with disease progression and see how they all compare.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02242773


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sanoj Punnen, MD, MAS University of Miami
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Responsible Party: Sanoj Punnen, MD, MAS, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02242773    
Other Study ID Numbers: 20140372
1R01CA189295-01 ( U.S. NIH Grant/Contract )
First Posted: September 17, 2014    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Sanoj Punnen, MD, MAS, University of Miami:
Active Surveillance
MRI-Guided Biopsy
Multi-parametric MRI
MP-MRI
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases