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MRI Based Active Selection for Treatment Trial (MAST)

Primary Purpose

Prostate Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-Parametric MRI
MRI-Guided Biopsy
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Active Surveillance, MRI-Guided Biopsy, Multi-parametric MRI, MP-MRI

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active Surveillance

Arm Description

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.

Outcomes

Primary Outcome Measures

Rate of Disease Progression within the first two surveillance biopsies
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.

Secondary Outcome Measures

Time-to-Biochemical Recurrence
The investigators will use recurrence after primary therapy to identify whether earlier identification of progression with MRI and MRI-US fusion biopsy will portend less recurrence compared to historical patients undergoing delayed primary surgery or radiation after initial surveillance. Biochemical recurrence (BCR) is defined as 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 between date of treatment and date of BCR if BCR occurs. The investigators will follow participants who have progressed and gone on to treatment.
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 SF-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.
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.
Area under Receiver Operating Characteristic (ROC) curve
The investigators will assess the incremental benefit of mpMRI, genomic risk test, and molecular markers compared to baseline NCCN risk classification for predicting progression on active surveillance. Area under the receiver operating characteristic Curve (ROC) curve 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.

Full Information

First Posted
September 13, 2014
Last Updated
September 28, 2023
Sponsor
University of Miami
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02242773
Brief Title
MRI Based Active Selection for Treatment Trial
Acronym
MAST
Official Title
MRI-Guided Active Selection for Treatment of Prostate Cancer: The Miami MAST Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 12, 2014 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Active Surveillance, MRI-Guided Biopsy, Multi-parametric MRI, MP-MRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Surveillance
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Multi-Parametric MRI
Intervention Description
Multi-Parametric MRI
Intervention Type
Device
Intervention Name(s)
MRI-Guided Biopsy
Intervention Description
MRI-Guided Biopsy
Primary Outcome Measure Information:
Title
Rate of Disease Progression within the first two surveillance biopsies
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Time-to-Biochemical Recurrence
Description
The investigators will use recurrence after primary therapy to identify whether earlier identification of progression with MRI and MRI-US fusion biopsy will portend less recurrence compared to historical patients undergoing delayed primary surgery or radiation after initial surveillance. Biochemical recurrence (BCR) is defined as 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 between date of treatment and date of BCR if BCR occurs. The investigators will follow participants who have progressed and gone on to treatment.
Time Frame
Up to 36 months
Title
Health-Related Quality of Life Scores: EPIC SF-12
Description
Health-Related Quality of Life will be assessed using scores from validated questionnaires. The Expanded Prostate Cancer Index Composite and Medical Outcomes Study SF-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.
Time Frame
Up to 36 months
Title
Health-Related Quality of Life Scores: MAX-PC
Description
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.
Time Frame
Up to 36 months
Title
Area under Receiver Operating Characteristic (ROC) curve
Description
The investigators will assess the incremental benefit of mpMRI, genomic risk test, and molecular markers compared to baseline NCCN risk classification for predicting progression on active surveillance. Area under the receiver operating characteristic Curve (ROC) curve 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.
Time Frame
Up to 36 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanoj Punnen, MD, MAS
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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MRI Based Active Selection for Treatment Trial

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