Prostate Cancer
Conditions
Brief summary
Whether a quantitative detection specfic magnetic resonance imaging (MRI) protocol improves prostate cancer (PCa) detection in biopsy naïve men is not adequately studied.
Detailed description
This will be a 2 arm prospective clinical trial. Men with clinical suspicion for PCa but no prior prostate biopsy will be enrolled from the University of Illinois (UI) Health Urology clinics. All eligible men will be screened and enrolled by the clinical research coordinator. Enrolled men will undergo detection protocol MRI at the UIC Advanced Imaging Center (AIC) prior to diagnostic biopsy. The MRI will be processed by the study team and evaluated for areas suspicious for high grade PCa by a board certified clinical radiologist. Subjects with MRI with no suspicious areas for high grade PCa will undergo standard of care (SOC) core transrectal ultrasound (TRUS) biopsy. Subject with MRI suspicious for high grade PCa will have 2-4 biopsies guided toward each suspicious lesion using MRI/TRUS fusion biopsies (maximum of 12 cores). All biopsies will undergo SOC histologic processing and interpretation in pathology. Biopsy results will be communicated to the patients by the Urologist performing the biopsy and all additional management will be SOC. This visit will signify the end of the study
Interventions
DEVICEUltrasound and MRI
A single subsequent ultrasound guided prostate biopsy with MRI fusion
DEVICEUltrasound
A single subsequent ultrasound guided prostate biopsy
Sponsors
University of Illinois at Chicago
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
50 men with clinical suspicion of PCa (elevated Prostate specific antigen (PSA) and/or abnormal DRE) will be enrolled into a prospective protocol and will undergo detection protocol MRI
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult men between 18 and 80 years of age * Suspected PCa as defined by elevated PSA ≥4 ng/mL and ≤20 ng/mL and/or abnormal DRE as determined by a physician * Ability to provide informed consent
Exclusion criteria
* Prior prostate biopsy * Prior diagnosis of PCa * MRI incompatible implanted medical devices or foreign bodies * Rectal anatomy incompatible with TRUS biopsy * Life expectancy \<10 years as determined by the treating urologist
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Grade or High Grade (Gleason Score 7 or Higher) Prostate Cancer as Measured by Histopathology | 19 months | Per subject prevalence of any grade or high grade (Gleason score 7 or higher) prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer |
| Number of Biopsy Samples With a Prevalence of High Grade (Gleason 7 or Higher) Prostate Cancer as Measured by Histopathology | 19 months | Per biopsy sample prevalence of high grade (Gleason 7 or higher) prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer |
| Number of Participants With PI-RADS 4-5 on MRI | 19 months | The accuracy of the mpMRI (PI-RADS version 2 score) to accurately characterize Gleason 7 or higher prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer |
| Number of Participants With PI-RADS <4 MRI | 19 months | The accuracy of the mpMRI (PI-RADS version 2 score) to accurately characterize Gleason 7 or higher prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer |
| Number of Participants That Had Adverse Events | 19 months | Adverse events of prostate biopsy using the Clavien-Dindo scale |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MRI and Ultrasound men with elevated PSA or abnormal DRE for which prostate biopsy is indicated and mpMRI positive for suspected prostate cancer followed by MRI/ultrasound fusion directed prostate needle biopsies
Ultrasound and MRI: A single subsequent ultrasound guided prostate biopsy with MRI fusion | 27 |
| Ultrasound men with elevated PSA or abnormal DRE for which prostate biopsy is indicated and mpMRI negative for suspected prostate cancer followed by standard ultrasound guided prostate needle biospies
Ultrasound: A single subsequent ultrasound guided prostate biopsy | 21 |
| Total | 48 |
Baseline characteristics
| Characteristic | MRI and Ultrasound | Ultrasound | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 9 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 12 Participants | 30 Participants |
| Age, Continuous | 61 years | 63 years | 62 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 5 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 16 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 7 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 11 Participants | 20 Participants |
| Region of Enrollment United States | 27 participants | 21 participants | 48 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 27 Participants | 21 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 21 |
| other Total, other adverse events | 0 / 27 | 0 / 21 |
| serious Total, serious adverse events | 0 / 27 | 0 / 21 |
Outcome results
Primary
Number of Biopsy Samples With a Prevalence of High Grade (Gleason 7 or Higher) Prostate Cancer as Measured by Histopathology
Per biopsy sample prevalence of high grade (Gleason 7 or higher) prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer
Time frame: 19 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| MRI and Ultrasound | Number of Biopsy Samples With a Prevalence of High Grade (Gleason 7 or Higher) Prostate Cancer as Measured by Histopathology | 8 Biopsy |
| Ultrasound | Number of Biopsy Samples With a Prevalence of High Grade (Gleason 7 or Higher) Prostate Cancer as Measured by Histopathology | 3 Biopsy |
Primary
Number of Participants That Had Adverse Events
Adverse events of prostate biopsy using the Clavien-Dindo scale
Time frame: 19 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MRI and Ultrasound | Number of Participants That Had Adverse Events | 0 Participants |
| Ultrasound | Number of Participants That Had Adverse Events | 0 Participants |
Primary
Number of Participants With Any Grade or High Grade (Gleason Score 7 or Higher) Prostate Cancer as Measured by Histopathology
Per subject prevalence of any grade or high grade (Gleason score 7 or higher) prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer
Time frame: 19 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MRI and Ultrasound | Number of Participants With Any Grade or High Grade (Gleason Score 7 or Higher) Prostate Cancer as Measured by Histopathology | 11 Participants |
| Ultrasound | Number of Participants With Any Grade or High Grade (Gleason Score 7 or Higher) Prostate Cancer as Measured by Histopathology | 8 Participants |
Primary
Number of Participants With PI-RADS 4-5 on MRI
The accuracy of the mpMRI (PI-RADS version 2 score) to accurately characterize Gleason 7 or higher prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer
Time frame: 19 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MRI and Ultrasound | Number of Participants With PI-RADS 4-5 on MRI | 23 Participants |
| Ultrasound | Number of Participants With PI-RADS 4-5 on MRI | 5 Participants |
Primary
Number of Participants With PI-RADS <4 MRI
The accuracy of the mpMRI (PI-RADS version 2 score) to accurately characterize Gleason 7 or higher prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer
Time frame: 19 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MRI and Ultrasound | Number of Participants With PI-RADS <4 MRI | 4 Participants |
| Ultrasound | Number of Participants With PI-RADS <4 MRI | 16 Participants |