Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

High Resolution MRI Study for Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03292874
Recruitment Status : Recruiting
First Posted : September 26, 2017
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Hyung L. Kim, MD, Cedars-Sinai Medical Center

Brief Summary:
This high resolution MRI (hrMRI), along with stand MRI (sMRI) will be obtained at baseline and again in approximately 1 year in patients on prostate cancer active surveillance. Changes in lesion size and ADC values will be assessed on the serial studies. This study evaluates the hypothesis that hrMRI will detect changes that sMRI cannot detect and that these changes will correlate with prostate cancer progression as determined on prostate biopsy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Diagnostic Test: high resolution MRI (hrMRI) Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, paired imaging
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of a Novel High-Resolution Diffusion-Weighted MRI Sequence
Actual Study Start Date : September 13, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Paired imaging
Single arm, paired imaging of high resolution MRI (hrMRI) and stand MRI (sMRI)
Diagnostic Test: high resolution MRI (hrMRI)
high resolution MRI (hrMRI) and standard MRI (sMRI) will be obtained at baseline and again in approximately 1 year in patients on prostate cancer active surveillance.




Primary Outcome Measures :
  1. Evidence of prostate cancer disease progression [ Time Frame: 3 years from baseline imaging ]

    evidence of disease progression as defined by any of the following:

    • Increase in Gleason score from 3 + 3 to Gleason sum 7 on biopsy
    • Gleason score 4+3 on biopsy
    • Gleason sum 8-10 on biopsy
    • > 3 Increase in number of positive cores
    • Progression to nodal or bone involvement



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 18 years
  • Patients diagnosed with clinically localized prostate cancer
  • Low or Low-intermediate Risk Prostate cancer1 defined as:
  • Pre-operative PSA ≤ 20.0 ng/ml
  • Clinical stage cT1 or cT2
  • Gleason score 3+3 or 3+4
  • Patients choosing AS or already on AS as primary management strategy
  • No previous treatment for prostate cancer with radiotherapy, chemotherapy, or hormonal therapy
  • No contraindications for gadolinium enhanced MRI

Exclusion Criteria:

  • No exclusion criteria

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): NCT03292874


Contacts
Layout table for location contacts
Contact: Jenny Park, MPH, CCRP 310-423-8762 jenny.park@cshs.org
Contact: Laura Sarmiento, CCRP 310-423-4295 laura.sarmiento@cshs.org

Locations
Layout table for location information
United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Jenny Park, MPH    310-423-8762    jenny.park@cshs.org   
Principal Investigator: Hyung L Kim, MD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Hyung L Kim, MD Cedars-Sinai Medical Center

Layout table for additonal information
Responsible Party: Hyung L. Kim, MD, Principal Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03292874     History of Changes
Other Study ID Numbers: Pro00049177
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019

Layout table for additional information
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

Keywords provided by Hyung L. Kim, MD, Cedars-Sinai Medical Center:
prostate cancer
MRI

Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases