Study Stopped
Unlikely to Accrue
Trial of Prostate Cancer Patients Undergoing Active Surveillance With or Without MRI-Guided Management
MGM
A Randomized Two-Arm Trial of Prostate Cancer Patients Undergoing Active Surveillance With or Without MRI-Guided Management: The MGM Trial
1 other identifier
observational
N/A
1 country
1
Brief Summary
- 1.Using multiparametric MRI Ultrasound-guided or MRI-guided biopsies will allow more accurate sampling of the tumors and therefore 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 Transrectal Ultrasound-guided biopsies.
- 2.Quality of life (QoL) will be similar in patients undergoing MRI Ultrasound or MRI-guided and Transrectal Ultrasound-guided biopsies.
- 3.Biomarker expression levels will correlate with biopsy progression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 18, 2013
CompletedFirst Posted
Study publicly available on registry
April 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedDecember 8, 2014
December 1, 2014
6 years
April 18, 2013
December 5, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of Progression in Subjects undergoing MRIus Biopsy vs Standard Ultrasound biopsy
To determine of multiparametric MRIus-guided biopsies increase the rate of progression on early (first two) biopsies in men undergoing active surveillance as compared with early detection using standard ultrasound biopsy.
42 months
Secondary Outcomes (2)
Expression Levels of Biomarkers from biopsies collected with MRI-us Biopsy vs Standard Ultrasound Biopsy
42 months
Effect of MRI Monitoring on Health-Related Quality of Life
42 months
Study Arms (2)
AS: Active Surveillance Alone
Active Surveillance Alone (AS). Transrectal Ultrasound-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies).
MRI-AS: MRI+ Active Surveillance
MRI-Managed Active Surveillance (MRI-AS). MRI Ultrasound or MRI-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies)
Interventions
Active Surveillance Alone (AS). Transrectal Ultrasound-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies).
MRI-Managed Active Surveillance (MRI-AS). MRI Ultrasound or MRI-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies)
Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
Plasma/Serum Sample for biomarkers obtained at Baseline, and at 12, 24 and 36 months after initial biopsy for correlative studies (CTC, fcDNA, SNPs)
Urine Sample for biomarkers obtained at Baseline, and at 12, 24, and 36 months for correlative studies (hypermethylated DNA)
Blood Tests for Blood Urea Nitrogen (BUN) and Creatinine obtained at 0 - 6 months, and at 12, 24, and 36 months from initial biopsy. This is optional, subject may refuse
Blood test for Serum PSA obtained at Baseline, at every 6 months up to 36 months from initial biopsy.
Eligibility Criteria
Low risk male patients with early stage T1 - T2a prostate adenocarcinoma, based on a digital rectal exam palpation. Patients must also have less than three positive cores with \< 50% of a single core; and Gleason score 3 + 3 = 6 or less.
You may qualify if:
- Biopsy confirmed adenocarcinoma of the prostate.
- Biopsy must consist of at least 8 cores.
- Enrollment is =\< 1 year from diagnosis.
- One or two biopsy cores with less than 50% tumor present in each core and Gleason score =\< 6 (3+3).
- Candidate for multiparametric MRI.
- T1-T2a disease based on digital rectal exam.
- No concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for \>= 5 years then the patient is eligible.
- Ability to understand and willingness to sign a written informed consent document
- Zubrod performance status \< 2.
- Patients must agree to fill out the psychosocial questionnaires.
- Age \>= 35 and =\< 75 years
You may not qualify if:
- Not biopsy confirmed adenocarcinoma of the prostate.
- Biopsy consists of less than 8 cores.
- Three or more biopsy cores are positive.
- Gleason score \>= 3+4=7.
- A single core has \>= 50% involvement with Gleason score =6 (3+3) or less.
- DCE-MRI study before enrollment.
- Inability to undergo MRI exam.
- Greater than T2a disease based on digital rectal exam.
- Concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for \< 5 years then the patient is ineligible
- Inability to understand or unwilling to sign a written informed consent document.
- Zubrod performance status \>= 2.
- Patient unwilling to fill out the psychosocial questionnaires.
- Age \< 35 or \> 75.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
Biospecimen
Biopsy tumor tissue, blood and urine samples for correlative studies (circulating tumor cells (CTC), free-circulating DNA (fcDNA) and single nucleotide polymorphisms (SNPs)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dipen Parekh, MD
University of Miami
- PRINCIPAL INVESTIGATOR
Alan Pollack, MD
University of Miami
- PRINCIPAL INVESTIGATOR
Sanoj Punnen, MD
University of Miami
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 18, 2013
First Posted
April 24, 2013
Study Start
August 1, 2012
Primary Completion
August 1, 2018
Last Updated
December 8, 2014
Record last verified: 2014-12