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MRI-Based Active Surveillance to AVoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Ca

2015-10-01 07:53:21 | BioPortfolio

Summary

Multiparametric MRI-based Active Surveillance to Avoid the Risks of Serial Biopsies in Men with Low-Risk Prostate Cancer (MAVERICK). Phase 2,Randomized control trial, unblinded, and non-inferiority. Low-risk prostate cancer without prior prostate MRI imaging.

Description

This is an unblinded, randomized trial of TRUS biopsy-based active surveillance versus mpMRI-based active surveillance. Patients on the TRUS biopsy-based arm will undergo annual systematic biopsies without any MRI staging or guidance. Patients on the mpMRI- based arm will undergo annual mpMRI surveillance imaging, with image-guided targeted biopsies only as indicated by radiographic findings.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Prostate Cancer

Intervention

TRUS-guided biopsy, mpMRI with targeted biopsy

Location

Hunter Holmes Mcguire Veteran Affairs Medical Center
Richmond
Virginia
United States
23249

Status

Not yet recruiting

Source

Virginia Commonwealth University

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-10-01T07:53:21-0400

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Medical and Biotech [MESH] Definitions

Conducting a biopsy procedure with the aid of a MEDICAL IMAGING modality.

A subtype of MICROSCOPIC COLITIS, characterized by chronic watery DIARRHEA of unknown origin, a normal COLONOSCOPY but abnormal histopathology on BIOPSY. Microscopic examination of biopsy samples taken from the COLON show larger-than-normal band of subepithelial COLLAGEN.

A subtype of MICROSCOPIC COLITIS, characterized by chronic watery DIARRHEA of unknown origin, a normal COLONOSCOPY but abnormal histopathology on BIOPSY. Microscopic examination of biopsy samples taken from the COLON show infiltration of LYMPHOCYTES in the superficial EPITHELIUM and the underlying connective tissue (lamina propria).

Conducting a fine needle biopsy with the aid of ENDOSCOPIC ULTRASONOGRAPHY.

Removal and pathologic examination of specimens in the form of small pieces of tissue from the living body.

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