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

Not Applicable

Active, not recruiting

• Conditions: Prostate Carcinoma

• Registration Number: NCT03697148
• Lead Sponsor: ECOG-ACRIN Cancer Research Group

Brief 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.

Study Timeline

• Study First Submitted: 2018-07-10
• Study First Submitted QC: 2018-10-03
• Study First Posted: 2018-10-05
• Study Start: 2019-02-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 852

Inclusion Criteria

• Recently diagnosed with prostate cancer for whom definitive surgical treatment is indicated

Exclusion Criteria

• Not suitable to undergo MRI or receive gadolinium-based contrast agent (severe, untreatable claustrophobia; MRI-incompatible metallic objects or implanted medical devices; renal failure; weight greater than allowable by scanner per institutional standard practice)
• Prior surgical and/or non-surgical treatment for prostate cancer
• Prior hip replacement or other major pelvic surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Risk prediction model	Up to 2 years	To estimate the predictive performance of a model for predicting clinically significant prostate cancer on the basis of the overall PI-RADS, PSA, Gleason score and clinical stage.
Diagnostic performance of overall prostate imaging reporting and data system (PI-RADS) score	Up to 2 years	Will estimate the diagnostic performance as quantified by the area under the ROC curve.

Secondary Outcome Measures

Name	Time	Method
Diagnostic performance of the individual prostate imaging reporting and data system (PI-RADS) score	Up to 2 years	Will estimate the diagnostic performance as quantified by the area under the ROC curve.

Trial Locations

Locations (44)

Mayo Clinic Hospital in Arizona; 🇺🇸 Phoenix, Arizona, United States

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

University of Florida Health Science Center - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Pali Momi Medical Center; 🇺🇸 'Aiea, Hawaii, United States

Straub Pearlridge Clinic; 🇺🇸 'Aiea, Hawaii, United States

Queen's Medical Center; 🇺🇸 Honolulu, Hawaii, United States

Straub Clinic and Hospital; 🇺🇸 Honolulu, Hawaii, United States

Midwestern Regional Medical Center; 🇺🇸 Zion, Illinois, United States

Scroll for more (34 remaining)