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High Resolution MRI Study for Prostate Cancer

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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Prostate Cancer
Intervention Diagnostic Test: high resolution MRI (hrMRI)
Enrollment 64
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paired Imaging
Hide Arm/Group Description

Single arm, paired imaging of high resolution MRI (hrMRI) and standard MRI (sMRI)

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.

Period Title: Overall Study
Started 64
Completed 59
Not Completed 5
Reason Not Completed
Due to pandemic             5
Arm/Group Title Paired Imaging
Hide Arm/Group Description

Single arm, paired imaging of high resolution MRI (hrMRI) and standard MRI (sMRI)

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.

Overall Number of Baseline Participants 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
  45.8%
>=65 years
32
  54.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants
65  (6.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
Female
0
   0.0%
Male
59
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
Hispanic or Latino
2
   3.4%
Not Hispanic or Latino
57
  96.6%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
American Indian or Alaska Native
0
   0.0%
Asian
7
  11.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
  10.2%
White
46
  78.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
PSA  
Mean (Standard Deviation)
Unit of measure:  Nanograms per milliliter
Number Analyzed 59 participants
6.0  (2.8)
Histologic Grade   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
Low grade (Gleason 3+3)
45
  76.3%
Intermediate grade (Gleason 3+4)
14
  23.7%
[1]
Measure Description: Histologic grade from prostate biopsy
No. positive cores on prostate biopsy   [1] 
Mean (Standard Deviation)
Unit of measure:  Number of positive cores
Number Analyzed 59 participants
2.9  (2.4)
[1]
Measure Description: Number of positive cores per patient on a standard prostate biopsy involving systematic sampling of the prostate.
No. prior biopsies  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
0
41
  69.5%
1
8
  13.6%
>1
10
  16.9%
Stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
T1c (non-palpable tumor)
58
  98.3%
T2a (palpable tumor)
1
   1.7%
[1]
Measure Description: Determined from digital rectal exam of the prostate
1.Primary Outcome
Title Sensitivity and Specificity of High Resolution Versus Standard MRI in Identifying Adverse Histology
Hide Description 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.
Time Frame 6-12 months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Each participant underwent both sMRI and hrMRI.
Arm/Group Title High Resolution MRI (hrMRI) Standard MRI (sMRI)
Hide Arm/Group Description:
All patients underwent hrMRI and sMRI.
All patients underwent hrMRI and sMRI.
Overall Number of Participants Analyzed 59 59
Measure Type: Number
Unit of Measure: percent
sensitivity 75 71
specificity 84 54.8
2.Primary Outcome
Title Area Under the Receiver Operator Curve of High Resolution Versus Standard MRI in Identifying Adverse Histology
Hide Description 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.
Time Frame 6-12 months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Each participant underwent both sMRI and hrMRI. Each was assess for predicting AH.
Arm/Group Title High Resolution MRI (hrMRI) Standard MRI (sMRI)
Hide Arm/Group Description:
All patients underwent hrMRI and sMRI.
All patients underwent hrMRI and sMRI.
Overall Number of Participants Analyzed 59 59
Measure Type: Number
Unit of Measure: probability
0.794 0.631
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Resolution MRI (hrMRI), Standard MRI (sMRI)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments

Areas under the receiver operating characteristics curve (AUC) were compared between models with standard and high-resolution MRI variables using the nonparametric method described by DeLong.

DeLong. Biometrics 1988;44(3):837-45.

Method nonparametric method
Comments [Not Specified]
Time Frame 12 months
Adverse Event Reporting Description This is an imaging study of a novel MRI.
 
Arm/Group Title hrMRI sMRI
Hide Arm/Group Description high resolution MRI standard MRI
All-Cause Mortality
hrMRI sMRI
Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)   0/59 (0.00%) 
Hide Serious Adverse Events
hrMRI sMRI
Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)   0/59 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
hrMRI sMRI
Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)   0/59 (0.00%) 
The number of patients in our study was relatively small. The reference standard was prostate biopsies, which is subject to sampling error. However, this was necessary when investigating a low-risk, small-volume cancer that is managed nonoperatively. Our study was performed at a single center and the imaging protocol was developed by our team.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Hyung L Kim
Organization: Cedars Sinai Medical Center
Phone: 310-423-4700
EMail: kimhl@cshs.org
Layout table for additonal information
Responsible Party: Hyung L. Kim, MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03292874    
Other Study ID Numbers: Pro00049177
First Submitted: September 21, 2017
First Posted: September 26, 2017
Results First Submitted: December 13, 2023
Results First Posted: April 3, 2024
Last Update Posted: April 3, 2024