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

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03697148

Enrollment

852

Registered

2018-10-05

Start date

2019-02-11

Completion date

2026-08-31

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Carcinoma

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.

Interventions

DIAGNOSTIC_TESTMultiparametric Magnetic Resonance Imaging

Undergo mpMRI

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

Measure	Time frame	Description
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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORClare Tempany-Afdhal

ECOG-ACRIN Cancer Research Group

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026