Trial Outcomes & Findings for Prostate Cancer Detection Screening MRI Protocol (NCT NCT04175730)
NCT ID: NCT04175730
Last Updated: 2022-06-09
Results Overview
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
COMPLETED
NA
48 participants
19 months
2022-06-09
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
21
|
|
Overall Study
COMPLETED
|
27
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prostate Cancer Detection Screening MRI Protocol
Baseline characteristics by cohort
| Measure |
MRI and Ultrasound
n=27 Participants
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
|
Ultrasound
n=21 Participants
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
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Age, Continuous
|
61 years
n=99 Participants
|
63 years
n=107 Participants
|
62 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=99 Participants
|
21 participants
n=107 Participants
|
48 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 19 monthsPer 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
Outcome measures
| Measure |
MRI and Ultrasound
n=27 Participants
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
|
Ultrasound
n=21 Participants
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
|
|---|---|---|
|
Number of Participants With Any Grade or High Grade (Gleason Score 7 or Higher) Prostate Cancer as Measured by Histopathology
|
11 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 19 monthsPer 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
Outcome measures
| Measure |
MRI and Ultrasound
n=151 Biopsy
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
|
Ultrasound
n=252 Biopsy
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
|
|---|---|---|
|
Number of Biopsy Samples With a Prevalence of High Grade (Gleason 7 or Higher) Prostate Cancer as Measured by Histopathology
|
8 Biopsy
|
3 Biopsy
|
PRIMARY outcome
Timeframe: 19 monthsThe 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
Outcome measures
| Measure |
MRI and Ultrasound
n=27 Participants
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
|
Ultrasound
n=21 Participants
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
|
|---|---|---|
|
Number of Participants With PI-RADS 4-5 on MRI
|
23 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 19 monthsThe 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
Outcome measures
| Measure |
MRI and Ultrasound
n=27 Participants
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
|
Ultrasound
n=21 Participants
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
|
|---|---|---|
|
Number of Participants With PI-RADS <4 MRI
|
4 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: 19 monthsAdverse events of prostate biopsy using the Clavien-Dindo scale
Outcome measures
| Measure |
MRI and Ultrasound
n=27 Participants
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
|
Ultrasound
n=21 Participants
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
|
|---|---|---|
|
Number of Participants That Had Adverse Events
|
0 Participants
|
0 Participants
|
Adverse Events
MRI and Ultrasound
Ultrasound
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place