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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03292874
Recruitment Status : Completed
First Posted : September 26, 2017
Results First Posted : April 3, 2024
Last Update Posted : April 3, 2024
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: N/A
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
Actual Primary Completion Date : December 14, 2022
Actual Study Completion Date : December 14, 2022

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. Sensitivity and Specificity of High Resolution Versus Standard MRI in Identifying Adverse Histology [ Time Frame: 6-12 months after enrollment ]
    The primary endpoint of the clinical trial was the presence of adverse histology (AH) on prostate biopsy. We defined adverse histology (AH) as either overall Gleason score of 7 or more on any biopsy, or an increase of 3 or more positive cores on serial systematic biopsies. The primary hypothesis was that change in tumor size or apparent diffusion coefficient (ADC) as detected by high resolution MRI (hrMRI) would better predict AH than standard MRI (sMRI). AH histology was a measure intended to capture patients with high Gleason grade component (i.e. Gleason Grade 4 or 5) and patients progressing (e.g. from Gleason Group 1 to Gleason Group 2 or from Gleason Group 2 to Gleason Group 3). The sample size was too small and the followup duration of approximately 12 months was too short to assess only true cancer progression as the endpoint. The presence of AH alone is clinically important since these patients may need close followup and may consider definitive local therapy.

  2. Area Under the Receiver Operator Curve of High Resolution Versus Standard MRI in Identifying Adverse Histology [ Time Frame: 6-12 months after enrollment ]
    The primary endpoint of the clinical trial was the presence of adverse histology (AH) on prostate biopsy. We defined adverse histology (AH) as either overall Gleason score of 7 or more on any biopsy, or an increase of 3 or more positive cores on serial systematic biopsies. The primary hypothesis was that change in tumor size or apparent diffusion coefficient (ADC) as detected by high resolution MRI (hrMRI) would better predict AH than standard MRI (sMRI). AH histology was a measure intended to capture patients with high Gleason grade component (i.e. Gleason Grade 4 or 5) and patients progressing (e.g. from Gleason Group 1 to Gleason Group 2 or from Gleason Group 2 to Gleason Group 3). The sample size was too small and the followup duration of approximately 12 months was too short to assess only true cancer progression as the endpoint. The presence of AH alone is clinically important since these patients may need close followup and may consider definitive local therapy.



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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 prostate specific antigen (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


Locations
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United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Hyung L Kim, MD Cedars-Sinai Medical Center
  Study Documents (Full-Text)

Documents provided by Hyung L. Kim, MD, Cedars-Sinai Medical Center:
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Responsible Party: Hyung L. Kim, MD, Principal Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03292874    
Other Study ID Numbers: Pro00049177
First Posted: September 26, 2017    Key Record Dates
Results First Posted: April 3, 2024
Last Update Posted: April 3, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
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:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases