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The Miami MAST Trial (MAST)

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ClinicalTrials.gov Identifier: NCT02242773
Recruitment Status : Recruiting
First Posted : September 17, 2014
Last Update Posted : April 3, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sanoj Punnen, University of Miami

Tracking Information
First Submitted Date  ICMJE September 13, 2014
First Posted Date  ICMJE September 17, 2014
Last Update Posted Date April 3, 2019
Actual Study Start Date  ICMJE November 12, 2014
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2014)
Rate of Disease Progression within the first two surveillance biopsies [ Time Frame: 36 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.
Change History Complete list of historical versions of study NCT02242773 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2016)
  • 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.
  • 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 ]
  • 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 ]
  • The Effect of Multiparametric MRI and MRI-US fusion biopsy on Study Participants Health-Related Quality of Life and Cancer-Specific Anxiety [ Time Frame: 36 months ]
    The effect of multiparametric MRI and MRI-US fusion biopsy on study participants' health related quality of life and cancer specific anxiety will be assessed using patient reported validated questionnaires.
  • Relation of Radiomics and Genomics Signatures to Existing Urine, Serum and Tissue Biomarkers Associated with Prostate Cancer Diagnosis and/or Progression. [ Time Frame: 36 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2014)
Percentage of patients reporting a significant change in quality of life and cancer-specific anxiety after undergoing the multiparametric MRI and MRI-US fusion biopsies. [ Time Frame: 36 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Miami MAST Trial
Official Title  ICMJE MRI-Guided Active Selection for Treatment of Prostate Cancer: The Miami MAST Trial
Brief Summary
  1. Multiparametric MRI ultrasound (MRIus)-guided or direct MRI-guided biopsies will allow for more directed sampling of the tumors from compartments with distinct multiparametric-MRI (MP-MRI) characteristics, termed habitats, that will increase the rate of "progression" on early (first and second) surveillance biopsies and decrease the rate of "progression" on late (third and further) surveillance biopsies compared to historic transrectal ultrasound (TRUS)-guided biopsy rates.
  2. Identifying higher risk tumor early on will reduce the proportions of patients with poor response to delayed primary treatment.
  3. Radiomics signatures from MP-MRI will define patterns that are associated with progression.
  4. Genomic signatures based on RNA from tumor tissue will define patterns that are associated with habitats and radiomics signatures, as well as progression.
Detailed Description Single arm therapeutic trial investigating the impact of MRI and MRI-US fusion biopsy to identify higher grade or volume tumors early on for better selection of patients for active surveillance and improved outcomes for those undergoing delayed treatment after initial observation.. MRI-US fusion biopsy will include targeting of suspicious areas seen on MRI as well as segmented sampling of the remaining gland. Patients will undergo MRI and MRI-US fusion biopsy within 3 months of enrollment in the trial and have repeat MRI-US fusion biopsies every year to assess overall rates and the temporal distribution of progression. Serum, urine and prostate biopsy tissue will be serially collected to investigate the association between various molecular biomarkers and radiologic and histological progression.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Device: Multi-Parametric MRI
    Multi-Parametric MRI
  • Device: MRI-Guided Biopsy
    MRI-Guided Biopsy
  • Behavioral: Expanded Prostate Cancer Index Composite SF12 Questionnaire
    Quality of Life Questionnaire administered to subjects at intervals defined by study protocol.
    Other Name: EPIC-SF12
  • Behavioral: Memory Anxiety Scale for Prostate Cancer patients
    Quality of Life Questionnaire administered to subjects at intervals defined by study protocol.
    Other Name: MAX-PC
  • Behavioral: Food Frequency Questionnaire
    Quality of Life Questionnaire administered at baseline
    Other Name: FFQ
Study Arms  ICMJE Experimental: Active Surveillance

Multi-parametric MRI and MRI-guided biopsy active surveillance of subjects with prostate cancer, including the following quality of life questionnaires:

  • Expanded Prostate Cancer Index Composite SF12 Questionnaire (EPIC-SF12);
  • Memory Anxiety Scale for Prostate Cancer patients (MAX-PC);
  • Food Frequency Questionnaire (FFQ)
Interventions:
  • Device: Multi-Parametric MRI
  • Device: MRI-Guided Biopsy
  • Behavioral: Expanded Prostate Cancer Index Composite SF12 Questionnaire
  • Behavioral: Memory Anxiety Scale for Prostate Cancer patients
  • Behavioral: Food Frequency Questionnaire
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 15, 2014)
165
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 35 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02242773
Other Study ID Numbers  ICMJE 20140372
1R01CA189295-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanoj Punnen, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Sanoj Punnen, MD University of Miami
PRS Account University of Miami
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP