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

Clinicaltrials.gov ID: NCT03697148
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 852

Conditions

Prostate Carcinoma

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.

Locations

29 locations Found with status Recruiting

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 855-776-0015

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 855-776-0015

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 800-237-1225

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 855-776-0015

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 314-251-7066

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 212-746-1848

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 215-728-4790

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

  • Site Public Contact
  • 877-469-5300

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Clare Tempany-Afdhal

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Clare Tempany-Afdhal

Eligibility Criteria

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 Plan

Diagnostic (mpMRI)

EXPERIMENTAL

Patients undergo mpMRI within 3 months prior to schedule surgery.

  • DIAGNOSTIC_TEST:

    Multiparametric Magnetic Resonance Imaging

    Description:

    Undergo mpMRI

Outcome Measures

Primary Outcome Measures

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

Time Frame: Up to 2 years

Risk prediction model

Time Frame: Up to 2 years

Secondary Outcome Measures

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

Time Frame: Up to 2 years

Timeline

  • Last Updated
    October 22, 2024
  • Start Date
    October 5, 2018
  • Today
    January 22, 2025
  • Completion Date ( Estimated )
    August 1, 2025

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