A Randomized Two-Arm Trial of Prostate Cancer Patients Undergoing Active Surveillance With or Without MRI-Guided Management: The MGM Trial
35 Years
75 Years
Male
Prostate Cancer, Prostate Adenocarcinoma
Trial Information
A Randomized Two-Arm Trial of Prostate Cancer Patients Undergoing Active Surveillance With or Without MRI-Guided Management: The MGM Trial
Favorable risk patients will be randomized to one of two active surveillance arms.
Stratification will be based on Prostate-specific antigen density (PSAD) (=< 0.15 vs > 0.15
ng/mL per mL), and number of positive cores in the diagnostic biopsy (1 vs 2):
- Arm I: Active Surveillance Alone (AS). TRUS guided biopsies at start (within 6 months
of enrollment) and at yearly intervals thereafter up to 36 months after the initial
biopsy (maximum four biopsies).
- Arm II: MRI-Managed Active Surveillance (MRI-AS). MRIus or MRI-guided biopsies at start
(within 6 months of enrollment) and at yearly intervals thereafter up to 36 months
after the initial biopsy (maximum four biopsies).
Patients will also complete Quality of Life (QoL) assessments to provide unique data on the
effects of MRI monitoring for patients undergoing active surveillance on QOL. The
investigators have selected a group of measures that have been used extensively in prostate
cancer populations.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Rate of Progression in Subjects undergoing MRIus Biopsy vs Standard Ultrasound biopsy
Outcome Description:
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.
Outcome Time Frame:
42 months
Safety Issue:
No
Principal Investigator
Mark Soloway, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Miami Institutional Review Board
Authority:
United States: Food and Drug Administration
Study ID:
EPROST-20120698
NCT ID:
NCT01838265
Start Date:
August 2012
Completion Date:
Related Keywords:
- Prostate Cancer
- Prostate Adenocarcinoma
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Prostatic Neoplasms
Name | Location |
|---|---|
| University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
