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
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: Multi-Parametric MRI Device: MRI-Guided Biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||207 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
Device: MRI-Guided Biopsy
- 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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Sanoj Punnen, MD, MAS||University of Miami|