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The Miami MAST Trial (MAST)

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Sanoj Punnen, University of Miami
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sanoj Punnen, University of Miami
ClinicalTrials.gov Identifier:
NCT02242773
First received: September 13, 2014
Last updated: April 11, 2017
Last verified: April 2017
  Purpose
  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.

Condition Intervention
Prostate Cancer 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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: MRI-Guided Active Selection for Treatment of Prostate Cancer: The Miami MAST Trial

Resource links provided by NLM:


Further study details as provided by Sanoj Punnen, University of Miami:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 165
Actual Study Start Date: November 12, 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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

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.
  Eligibility

Ages Eligible for Study:   35 Years to 85 Years   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02242773

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Sanoj Punnen, MD    305-243-6596    S.Punnen@med.miami.edu   
Principal Investigator: Dipen Parekh, MD         
Principal Investigator: Alan Pollack, MD         
Principal Investigator: Sanoj Punnen, MD         
Sponsors and Collaborators
University of Miami
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Sanoj Punnen, MD University of Miami
  More Information

Responsible Party: Sanoj Punnen, Assistant Professor of Clinical, University of Miami
ClinicalTrials.gov Identifier: NCT02242773     History of Changes
Other Study ID Numbers: 20140372
1R01CA189295-01 ( US NIH Grant/Contract Award Number )
Study First Received: September 13, 2014
Last Updated: April 11, 2017

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

Keywords provided by Sanoj Punnen, University of Miami:
Prostate Cancer
Active Surveillance
MRI-Guided Biopsy
Multi-parametric MRI
MP-MRI

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on June 22, 2017