NCT03697148

Multiparametric MRI in Evaluating Cancer Stage and Helping Treatment Planning in Patients With Prostate Cancer

Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 852 (estimated)
• Sponsor: ECOG-ACRIN Cancer Research Group · Network
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well multiparametric magnetic resonance imaging (MRI) works in evaluating cancer stage and helping treatment planning in patients with prostate cancer. Multiparametric MRI may be useful for evaluating the type of cancer in finding aggressive disease.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the diagnostic performance as quantified by the area under the ROC curve to detect aggressive prostate cancer. II. To develop a risk prediction model by incorporating overall PI-RADS, PSA, Gleason score and clinical stage to predict the presence of aggressive prostate cancer. SECONDARY OBJECTIVES: I. To evaluate the diagnostic performance of the individual PI-RADS score of each MRI parameter (T2W, DWI and DCE), as determined by local imaging review. TERTIARY OBJECTIVES: I. All clinical data including magnetic resonance (MR) images will be banked for future exploratory research aims. OUTLINE: Patients undergo mpMRI within 3 months prior to schedule surgery. After completion of study, patients are followed up until radical prostatectomy pathology is reported and finalized.

Conditions

• Prostate Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Multiparametric Magnetic Resonance Imaging	Undergo mpMRI

Timeline

• Start date: 2019-02-11
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2018-10-05
• Last updated: 2026-03-23

Locations

44 sites across 1 country: United States

Regulatory

• FDA-regulated device study