Trial of Prostate Cancer Patients Undergoing Active Surveillance With or Without MRI-Guided Management

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

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.

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.