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A Randomized Two-Arm Trial of Prostate Cancer Patients Undergoing Active Surveillance With or Without MRI-Guided Management: The MGM Trial


N/A
35 Years
75 Years
Open (Enrolling)
Male
Prostate Cancer, Prostate Adenocarcinoma

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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 CenterMiami, Florida  33136