NCT01838265

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: Male
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Prostate Cancer
• Prostate Adenocarcinoma

Interventions

Type	Name	Description
PROCEDURE	Transrectal Ultrasound-Guided Biopsy	Active Surveillance Alone (AS). Transrectal Ultrasound-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies).
PROCEDURE	MRI Ultrasound Biopsy	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)
BEHAVIORAL	Expanded Prostate Cancer index Composite Questionnaire	Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
BEHAVIORAL	Short-Form 12 of Health Related Quality of Life Questionnaire	Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
BEHAVIORAL	Memorial Anxiety Scale for Prostate Cancer	Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
PROCEDURE	Plasma/Serum Sample for biomarkers	Plasma/Serum Sample for biomarkers obtained at Baseline, and at 12, 24 and 36 months after initial biopsy for correlative studies (CTC, fcDNA, SNPs)
PROCEDURE	Urine Sample for Biomarkers	Urine Sample for biomarkers obtained at Baseline, and at 12, 24, and 36 months for correlative studies (hypermethylated DNA)
PROCEDURE	Blood Tests for Blood Urea Nitrogen and Creatinine	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
PROCEDURE	Blood Test for Serum PSA	Blood test for Serum PSA obtained at Baseline, at every 6 months up to 36 months from initial biopsy.

Timeline

• Start date: 2012-08-01
• Primary completion: 2018-08-01
• First posted: 2013-04-24
• Last updated: 2014-12-08

Locations

1 site across 1 country: United States