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

ECOG-ACRIN Cancer Research Group

Status: Active, not recruiting

Conditions: Prostate Carcinoma

Treatments: Diagnostic Test: Multiparametric Magnetic Resonance Imaging

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT03697148

NCI-2017-01997 (Registry Identifier)

U10CA180820 (U.S. NIH Grant/Contract)

EA8171 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 852 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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852 participants in 1 patient group

Diagnostic (mpMRI)

Experimental group

Description:

Patients undergo mpMRI within 3 months prior to schedule surgery.

Treatment:

Diagnostic Test: Multiparametric Magnetic Resonance Imaging