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NCT Number: NCT03697148

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multiparametric Magnetic Resonance Imaging

Diagnostic Test

Undergo mpMRI

Other names: MP-MRI, Multi-parametric MRI, Multiparametric MRI

Primary outcomes

  1. Diagnostic performance of overall prostate imaging reporting and data system (PI-RADS) score

    Time frame: Up to 2 years

    Will estimate the diagnostic performance as quantified by the area under the ROC curve.

  2. Risk prediction model

    Time frame: 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 outcomes

  1. Diagnostic performance of the individual prostate imaging reporting and data system (PI-RADS) score

    Time frame: Up to 2 years

    Will estimate the diagnostic performance as quantified by the area under the ROC curve.

Sponsors and collaborators

Lead sponsor

ECOG-ACRIN Cancer Research Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Oct 5, 2018
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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