Trial Outcomes & Findings for ARFI Imaging for Targeted Prostate Biopsy (NCT NCT04607135)
NCT ID: NCT04607135
Last Updated: 2025-05-06
Results Overview
TERMINATED
NA
34 participants
Up to 30 minutes
2025-05-06
Participant Flow
Recruitment for this study took place from October 2021 to March 2023.
Record and results are representative of Part 2 of the protocol. The results of Part 1 were not intended to be reported with Part 2.
Participant milestones
| Measure |
Patients With Suspected PCa Who Are Scheduled to Undergo an Ultrasound Fusion-MR Prostate Biopsy
Acoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.
Ultrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.
Systematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
Acoustic Radiation Force Impulse (ARFI)
|
30
|
|
Overall Study
MR-ultrasound Fusion
|
29
|
|
Overall Study
Systematic Sampling
|
30
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Patients With Suspected PCa Who Are Scheduled to Undergo an Ultrasound Fusion-MR Prostate Biopsy
Acoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.
Ultrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.
Systematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Equipment not working
|
3
|
Baseline Characteristics
ARFI Imaging for Targeted Prostate Biopsy
Baseline characteristics by cohort
| Measure |
Patients With Suspected PCa Who Are Scheduled to Undergo an Ultrasound Fusion-MR Prostate Biopsy
n=34 Participants
Acoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.
Ultrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.
Systematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.
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|---|---|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 6.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 30 minutesPopulation: Participants who were imaged with that biopsy approach and in whom cancer of any grade was detected by any biopsy approach. All but one participant underwent all three types of biopsy. One subject did not undergo MR-ultrasound fusion biopsy, but did complete the other two procedures.
Outcome measures
| Measure |
Acoustic Radiation Force Impulse (ARFI)
n=27 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Acoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.
|
MR-ultrasound Fusion
n=26 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Ultrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.
|
Systematic Sampling
n=27 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Systematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.
|
|---|---|---|---|
|
Number of Participants in Whom the Biopsy Approach Detected the Presence of Prostate Cancer (PCa) of Any Grade
|
13 Participants
|
22 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: Up to 30 minutesPopulation: Participants in whom cancer was detected by a given biopsy approach.
Length of carcinoma per cancer-positive biopsy specimen as reported by the pathology findings, computed from all cancer-positive biopsy specimens from a given biopsy approach for each participant in whom cancer of any grade was detected by any biopsy approach.
Outcome measures
| Measure |
Acoustic Radiation Force Impulse (ARFI)
n=13 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Acoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.
|
MR-ultrasound Fusion
n=22 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Ultrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.
|
Systematic Sampling
n=23 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Systematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.
|
|---|---|---|---|
|
Length of Cancerous Tissue
|
9.5 mm
Standard Deviation 11.2
|
15.8 mm
Standard Deviation 10.3
|
4.9 mm
Standard Deviation 3.0
|
PRIMARY outcome
Timeframe: Up to 30 minutesPopulation: Participants in whom cancer was detected by a given biopsy approach.
The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk. For each subject, the highest grade group detected by a given biopsy approach is assigned to that subject for that biopsy approach.
Outcome measures
| Measure |
Acoustic Radiation Force Impulse (ARFI)
n=13 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Acoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.
|
MR-ultrasound Fusion
n=22 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Ultrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.
|
Systematic Sampling
n=23 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Systematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.
|
|---|---|---|---|
|
Grade Group of Cancerous Tissue
|
1.92 units on a scale
Standard Deviation 1.04
|
1.86 units on a scale
Standard Deviation 0.83
|
1.96 units on a scale
Standard Deviation 1.15
|
PRIMARY outcome
Timeframe: Up to 30 minutesPopulation: Participants in whom cancer was detected by each biopsy approach.
A commonly used method to classify how cells appear in cancerous tissues; the less the cancerous cells look like normal cells, the more malignant the cancer; two numbers, each from 1 to 5, are assigned to the two most predominant types of cells present. These two numbers are added together to produce the Gleason score with a total range of 2 to 10. Higher numbers indicate more aggressive cancers. For each subject, the highest Gleason score detected by a given biopsy approach is assigned to that subject for that biopsy approach.
Outcome measures
| Measure |
Acoustic Radiation Force Impulse (ARFI)
n=13 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Acoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.
|
MR-ultrasound Fusion
n=22 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Ultrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.
|
Systematic Sampling
n=23 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Systematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.
|
|---|---|---|---|
|
Gleason Score
|
6.62 score on a scale
Standard Deviation 0.65
|
6.77 score on a scale
Standard Deviation 0.61
|
6.74 score on a scale
Standard Deviation 0.81
|
PRIMARY outcome
Timeframe: Up to 30 minutesPopulation: Participants in whom Grade Group 1 was the highest grade of cancer that was detected by any biopsy approach.
The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.
Outcome measures
| Measure |
Acoustic Radiation Force Impulse (ARFI)
n=8 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Acoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.
|
MR-ultrasound Fusion
n=8 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Ultrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.
|
Systematic Sampling
n=8 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Systematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.
|
|---|---|---|---|
|
Number of Participants With Grade Group 1 Cancer, In Whom Cancer Was Detected
|
2 Participants
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 30 minutesPopulation: Participants in whom Grade Group 2 was the highest grade of cancer that was detected by any biopsy approach.
The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.
Outcome measures
| Measure |
Acoustic Radiation Force Impulse (ARFI)
n=13 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Acoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.
|
MR-ultrasound Fusion
n=13 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Ultrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.
|
Systematic Sampling
n=13 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Systematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.
|
|---|---|---|---|
|
Number of Participants With Grade Group 2 Cancer, In Whom Cancer (of Any Grade) Was Detected
|
7 Participants
|
12 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Up to 30 minutesPopulation: Participants in whom Grade Group 2 was the highest grade of cancer that was detected by any biopsy approach.
The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.
Outcome measures
| Measure |
Acoustic Radiation Force Impulse (ARFI)
n=13 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Acoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.
|
MR-ultrasound Fusion
n=13 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Ultrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.
|
Systematic Sampling
n=13 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Systematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.
|
|---|---|---|---|
|
Number of Participants With Grade Group 2 Cancer, Graded as Grade Group 2
|
3 Participants
|
11 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Up to 30 minutesPopulation: Participants who were imaged with that biopsy approach and in whom Grade Group 3 was the highest grade of cancer that was detected by any biopsy approach.
The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.
Outcome measures
| Measure |
Acoustic Radiation Force Impulse (ARFI)
n=3 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Acoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.
|
MR-ultrasound Fusion
n=2 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Ultrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.
|
Systematic Sampling
n=3 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Systematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.
|
|---|---|---|---|
|
Number of Participants With Grade Group 3 Cancer, In Whom Cancer (of Any Grade) Was Detected
|
1 Participants
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 30 minutesPopulation: Participants who were imaged with that biopsy approach and in whom Grade Group 3 was the highest grade of cancer that was detected by any biopsy approach.
The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.
Outcome measures
| Measure |
Acoustic Radiation Force Impulse (ARFI)
n=3 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Acoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.
|
MR-ultrasound Fusion
n=2 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Ultrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.
|
Systematic Sampling
n=3 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Systematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.
|
|---|---|---|---|
|
Number of Participants With Grade Group 3 Cancer, Graded as Grade Group 3
|
1 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 30 minutesPopulation: Participants in whom Grade Group 4 was the highest grade of cancer that was detected by any biopsy approach.
The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.
Outcome measures
| Measure |
Acoustic Radiation Force Impulse (ARFI)
n=2 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Acoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.
|
MR-ultrasound Fusion
n=2 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Ultrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.
|
Systematic Sampling
n=2 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Systematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.
|
|---|---|---|---|
|
Number of Participants With Grade Group 4 Cancer, In Whom Cancer (of Any Grade) Was Detected
|
2 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 30 minutesPopulation: Participants in whom Grade Group 4 was the highest grade of cancer that was detected by any biopsy approach.
The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.
Outcome measures
| Measure |
Acoustic Radiation Force Impulse (ARFI)
n=2 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Acoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.
|
MR-ultrasound Fusion
n=2 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Ultrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.
|
Systematic Sampling
n=2 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Systematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.
|
|---|---|---|---|
|
Number of Participants With Grade Group 4 Cancer, Graded as Grade Group 4
|
0 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 30 minutesPopulation: Participants in whom Grade Group 5 was the highest grade of cancer that was detected by any biopsy approach.
The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.
Outcome measures
| Measure |
Acoustic Radiation Force Impulse (ARFI)
n=1 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Acoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.
|
MR-ultrasound Fusion
n=1 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Ultrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.
|
Systematic Sampling
n=1 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Systematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.
|
|---|---|---|---|
|
Number of Participants With Grade Group 5 Cancer, In Whom Cancer (of Any Grade) Was Detected
|
1 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 30 minutesPopulation: Participants in whom Grade Group 5 was the highest grade of cancer that was detected by any biopsy approach.
The grading system has five grade groups, 1 to 5. Grade group 1 (Gleason score ≤ 6) represents low or very low risk; grade groups 2 and 3 (Gleason score 3+4=7 and 4+3=7, respectively) represent intermediate risk; and grade groups 4 and 5 (Gleason score 8 and 9-10, respectively) represent high and very high risk.
Outcome measures
| Measure |
Acoustic Radiation Force Impulse (ARFI)
n=1 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Acoustic radiation force impulse (ARFI): Sound waves are sent in a series and are expected to "push on" the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system. Regions suspicious for cancer in ARFI images are biopsied under ARFI imaging guidance.
|
MR-ultrasound Fusion
n=1 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Ultrasound: Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen. MR fusion methods are used to provide imaging guidance to target biopsies.
|
Systematic Sampling
n=1 Participants
Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Systematic sampling: Biopsy specimens are obtained by sampling 12 pre-specified locations in the prostate, with standard ultrasound imaging guidance.
|
|---|---|---|---|
|
Number of Participants With Grade Group 5 Cancer, Graded as Grade Group 5
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Acoustic Radiation Force Impulse (ARFI)
MR-ultrasound Fusion
Systematic Sampling
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