MR Imaging and MR Spectroscopic Imaging of Prostate Cancer Prior to Radical Prostatectomy: A Prospective Multi-Institutional Clinicopathological Study

Protocol Documents

Protocol-ACRIN 6659 Amendment 5, 7.16.03 [PDF]

SOC-ACRIN 6659 Amendment 5, 7.16.03 [PDF]


Principal Investigator: Jeffrey C. Weinreb, MD

Status: Accrual Complete; Analysis & Publications in Process

Main Objective: The primary aim of this protocol is to evaluate the accuracy of combined magnetic resonance imaging (MRI) and magnetic resonance spectroscopic imaging (MRSI) performed at multiple institutions in the localization of prostate cancer and its incremental benefit on diagnostic accuracy when compared to MRI alone.

Participants:  One hundred and thirty-four persons with biopsy-proven adenocarcinoma of the prostate who are scheduled to undergo a radical prostatectomy at the participating institution.

Study Design Summary:  Participants will undergo preoperative combined MRI/MRSI at one of seven institutions.  Five independent readers will interpret all scans. Reference information will be derived from central pathological examination of surgical specimens. The primary endpoint is the evaluation of the presence of a tumor in a sextant of the prostate. The unit of analysis for the primary endpoint will be a single sextant.