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

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ClinicalTrials.gov Identifier: NCT03697148
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : October 5, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( 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.

Condition or disease Intervention/treatment Phase
Prostate Carcinoma Procedure: Multiparametric Magnetic Resonance Imaging Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 852 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnostic (mpMRI)
Patients undergo mpMRI within 3 months prior to schedule surgery.
Procedure: Multiparametric Magnetic Resonance Imaging
Undergo mpMRI
Other Names:
  • MP-MRI
  • Multi-parametric MRI
  • Multiparametric MRI




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697148


Locations
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United States, Pennsylvania
ECOG-ACRIN Cancer Research Group Recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact: Clare M. Tempany-Afdhal    617-732-8772    ctempany@bwh.harvard.edu   
Principal Investigator: Clare M. Tempany-Afdhal         
Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Clare Tempany-Afdhal ECOG-ACRIN Cancer Research Group

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Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT03697148     History of Changes
Other Study ID Numbers: EA8171
NCI-2017-01997 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
EA8171 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
EA8171 ( Other Identifier: CTEP )
U10CA180820 ( U.S. NIH Grant/Contract )
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases