Trial Outcomes & Findings for Prostate Cancer Detection Screening MRI Protocol (NCT 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

Recruitment status

COMPLETED

Study phase

Target enrollment

48 participants

Primary outcome timeframe

19 months

Results posted on

2022-06-09

Participant Flow

Participant milestones

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

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=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Age, Continuous	61 years n=5 Participants	63 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	21 Participants n=7 Participants	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	16 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	7 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	21 participants n=7 Participants	48 participants n=5 Participants

PRIMARY outcome

Timeframe: 19 months

Outcome measures

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 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

Outcome measures

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 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

Outcome measures

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 months

Outcome measures

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 months

Adverse events of prostate biopsy using the Clavien-Dindo scale

Outcome measures

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ultrasound

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Abern

University of Illinois at Chicago

Phone: 312-996-9330

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place