Prostate Cancer
Conditions
Keywords
Transrectal Ultrasound, Prostate biopsy
Brief summary
The purpose of this study is to evaluate a new ultrasound technique. This technique may provide additional and improved information about the stiffness and sizes of the internal structures of your prostate in order to improve the guidance for a targeted biopsy. The investigational, custom-designed probe and needle guide will be used to produce images of your prostate and provide guidance for up to 4 additional biopsy samples (cores) prior to a standard magnetic resonance (MR) ultrasound fusion biopsy procedure. Above the time required for the MR ultrasound fusion biopsy, this study will take up to 30 additional minutes of time for collection of the investigational device guided collection of biopsy samples Risks of participation include increased time under anesthesia (to collect additional biopsies) and slight heating of tissue.
Interventions
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
DEVICEUltrasound
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
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men who are scheduled to undergo ultrasound fusion-MR prostate biopsy; * Men who are willing to participate in the study; * Subjects must freely sign informed consent to enroll in the study; * Assessing eligibility: eligibility for the study will be assessed, based upon the above criteria, by the participating urologist at the time of consultation. * 18 years or older
Exclusion criteria
* Men who have had previous treatment for PCa including radiation, cryoablation, chemotherapy, surgery, high intensity focused ultrasound (HIFU), laser therapy or hormone therapy; * Men who have had previous non-pharmacological invasive or minimally invasive treatment for benign prostatic hypertrophy (BPH) (i.e., TURP, TUMPT, WIT, TUNA, etc); * standard pharmacological treatment of BPH is allowable * Men who are mentally impaired and cannot give written consent; * Men with anomalies of the rectum.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in Whom the Biopsy Approach Detected the Presence of Prostate Cancer (PCa) of Any Grade | Up to 30 minutes | — |
| Length of Cancerous Tissue | Up to 30 minutes | 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. |
| Grade Group of Cancerous Tissue | Up to 30 minutes | 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. |
| Gleason Score | Up to 30 minutes | 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. |
| Number of Participants With Grade Group 1 Cancer, In Whom Cancer Was Detected | Up to 30 minutes | 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. |
| Number of Participants With Grade Group 2 Cancer, In Whom Cancer (of Any Grade) Was Detected | Up to 30 minutes | 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. |
| Number of Participants With Grade Group 2 Cancer, Graded as Grade Group 2 | Up to 30 minutes | 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. |
| Number of Participants With Grade Group 3 Cancer, In Whom Cancer (of Any Grade) Was Detected | Up to 30 minutes | 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. |
| Number of Participants With Grade Group 3 Cancer, Graded as Grade Group 3 | Up to 30 minutes | 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. |
| Number of Participants With Grade Group 4 Cancer, In Whom Cancer (of Any Grade) Was Detected | Up to 30 minutes | 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. |
| Number of Participants With Grade Group 4 Cancer, Graded as Grade Group 4 | Up to 30 minutes | 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. |
| Number of Participants With Grade Group 5 Cancer, In Whom Cancer (of Any Grade) Was Detected | Up to 30 minutes | 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. |
| Number of Participants With Grade Group 5 Cancer, Graded as Grade Group 5 | Up to 30 minutes | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment for this study took place from October 2021 to March 2023.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Equipment not working | 3 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Patients With Suspected PCa Who Are Scheduled to Undergo an Ultrasound Fusion-MR Prostate Biopsy |
|---|---|
| Age, Continuous | 63.9 years STANDARD_DEVIATION 6.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Region of Enrollment United States | 34 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 34 | 0 / 34 |
| other Total, other adverse events | 0 / 34 | 0 / 34 | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 | 0 / 34 |
Outcome results
Primary
Gleason Score
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.
Time frame: Up to 30 minutes
Population: Participants in whom cancer was detected by each biopsy approach.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acoustic Radiation Force Impulse (ARFI) | Gleason Score | 6.62 score on a scale | Standard Deviation 0.65 |
| MR-ultrasound Fusion | Gleason Score | 6.77 score on a scale | Standard Deviation 0.61 |
| Systematic Sampling | Gleason Score | 6.74 score on a scale | Standard Deviation 0.81 |
p-value: 0.74Kruskal-Wallis
Primary
Grade Group of Cancerous Tissue
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.
Time frame: Up to 30 minutes
Population: Participants in whom cancer was detected by a given biopsy approach.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acoustic Radiation Force Impulse (ARFI) | Grade Group of Cancerous Tissue | 1.92 units on a scale | Standard Deviation 1.04 |
| MR-ultrasound Fusion | Grade Group of Cancerous Tissue | 1.86 units on a scale | Standard Deviation 0.83 |
| Systematic Sampling | Grade Group of Cancerous Tissue | 1.96 units on a scale | Standard Deviation 1.15 |
p-value: 0.99Kruskal-Wallis
Primary
Length of Cancerous Tissue
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.
Time frame: Up to 30 minutes
Population: Participants in whom cancer was detected by a given biopsy approach.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acoustic Radiation Force Impulse (ARFI) | Length of Cancerous Tissue | 9.5 mm | Standard Deviation 11.2 |
| MR-ultrasound Fusion | Length of Cancerous Tissue | 15.8 mm | Standard Deviation 10.3 |
| Systematic Sampling | Length of Cancerous Tissue | 4.9 mm | Standard Deviation 3 |
p-value: 0.0003Welch's ANOVA
p-value: 0.002Games-Howell post-hoc test
p-value: 0.24Games-Howell post-hoc test
p-value: 0.35Games-Howell post-hoc test
Primary
Number of Participants in Whom the Biopsy Approach Detected the Presence of Prostate Cancer (PCa) of Any Grade
Time frame: Up to 30 minutes
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acoustic Radiation Force Impulse (ARFI) | Number of Participants in Whom the Biopsy Approach Detected the Presence of Prostate Cancer (PCa) of Any Grade | 13 Participants |
| MR-ultrasound Fusion | Number of Participants in Whom the Biopsy Approach Detected the Presence of Prostate Cancer (PCa) of Any Grade | 22 Participants |
| Systematic Sampling | Number of Participants in Whom the Biopsy Approach Detected the Presence of Prostate Cancer (PCa) of Any Grade | 23 Participants |
Primary
Number of Participants With Grade Group 1 Cancer, In Whom Cancer Was Detected
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.
Time frame: Up to 30 minutes
Population: Participants in whom Grade Group 1 was the highest grade of cancer that was detected by any biopsy approach.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acoustic Radiation Force Impulse (ARFI) | Number of Participants With Grade Group 1 Cancer, In Whom Cancer Was Detected | 2 Participants |
| MR-ultrasound Fusion | Number of Participants With Grade Group 1 Cancer, In Whom Cancer Was Detected | 6 Participants |
| Systematic Sampling | Number of Participants With Grade Group 1 Cancer, In Whom Cancer Was Detected | 6 Participants |
Primary
Number of Participants With Grade Group 2 Cancer, Graded as Grade Group 2
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.
Time frame: Up to 30 minutes
Population: Participants in whom Grade Group 2 was the highest grade of cancer that was detected by any biopsy approach.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acoustic Radiation Force Impulse (ARFI) | Number of Participants With Grade Group 2 Cancer, Graded as Grade Group 2 | 3 Participants |
| MR-ultrasound Fusion | Number of Participants With Grade Group 2 Cancer, Graded as Grade Group 2 | 11 Participants |
| Systematic Sampling | Number of Participants With Grade Group 2 Cancer, Graded as Grade Group 2 | 8 Participants |
Primary
Number of Participants With Grade Group 2 Cancer, In Whom Cancer (of Any Grade) Was Detected
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.
Time frame: Up to 30 minutes
Population: Participants in whom Grade Group 2 was the highest grade of cancer that was detected by any biopsy approach.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acoustic Radiation Force Impulse (ARFI) | Number of Participants With Grade Group 2 Cancer, In Whom Cancer (of Any Grade) Was Detected | 7 Participants |
| MR-ultrasound Fusion | Number of Participants With Grade Group 2 Cancer, In Whom Cancer (of Any Grade) Was Detected | 12 Participants |
| Systematic Sampling | Number of Participants With Grade Group 2 Cancer, In Whom Cancer (of Any Grade) Was Detected | 11 Participants |
Primary
Number of Participants With Grade Group 3 Cancer, Graded as Grade Group 3
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.
Time frame: Up to 30 minutes
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acoustic Radiation Force Impulse (ARFI) | Number of Participants With Grade Group 3 Cancer, Graded as Grade Group 3 | 1 Participants |
| MR-ultrasound Fusion | Number of Participants With Grade Group 3 Cancer, Graded as Grade Group 3 | 0 Participants |
| Systematic Sampling | Number of Participants With Grade Group 3 Cancer, Graded as Grade Group 3 | 2 Participants |
Primary
Number of Participants With Grade Group 3 Cancer, In Whom Cancer (of Any Grade) Was Detected
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.
Time frame: Up to 30 minutes
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acoustic Radiation Force Impulse (ARFI) | Number of Participants With Grade Group 3 Cancer, In Whom Cancer (of Any Grade) Was Detected | 1 Participants |
| MR-ultrasound Fusion | Number of Participants With Grade Group 3 Cancer, In Whom Cancer (of Any Grade) Was Detected | 1 Participants |
| Systematic Sampling | Number of Participants With Grade Group 3 Cancer, In Whom Cancer (of Any Grade) Was Detected | 3 Participants |
Primary
Number of Participants With Grade Group 4 Cancer, Graded as Grade Group 4
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.
Time frame: Up to 30 minutes
Population: Participants in whom Grade Group 4 was the highest grade of cancer that was detected by any biopsy approach.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acoustic Radiation Force Impulse (ARFI) | Number of Participants With Grade Group 4 Cancer, Graded as Grade Group 4 | 0 Participants |
| MR-ultrasound Fusion | Number of Participants With Grade Group 4 Cancer, Graded as Grade Group 4 | 1 Participants |
| Systematic Sampling | Number of Participants With Grade Group 4 Cancer, Graded as Grade Group 4 | 2 Participants |
Primary
Number of Participants With Grade Group 4 Cancer, In Whom Cancer (of Any Grade) Was Detected
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.
Time frame: Up to 30 minutes
Population: Participants in whom Grade Group 4 was the highest grade of cancer that was detected by any biopsy approach.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acoustic Radiation Force Impulse (ARFI) | Number of Participants With Grade Group 4 Cancer, In Whom Cancer (of Any Grade) Was Detected | 2 Participants |
| MR-ultrasound Fusion | Number of Participants With Grade Group 4 Cancer, In Whom Cancer (of Any Grade) Was Detected | 2 Participants |
| Systematic Sampling | Number of Participants With Grade Group 4 Cancer, In Whom Cancer (of Any Grade) Was Detected | 2 Participants |
Primary
Number of Participants With Grade Group 5 Cancer, Graded as Grade Group 5
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.
Time frame: Up to 30 minutes
Population: Participants in whom Grade Group 5 was the highest grade of cancer that was detected by any biopsy approach.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acoustic Radiation Force Impulse (ARFI) | Number of Participants With Grade Group 5 Cancer, Graded as Grade Group 5 | 0 Participants |
| MR-ultrasound Fusion | Number of Participants With Grade Group 5 Cancer, Graded as Grade Group 5 | 0 Participants |
| Systematic Sampling | Number of Participants With Grade Group 5 Cancer, Graded as Grade Group 5 | 1 Participants |
Primary
Number of Participants With Grade Group 5 Cancer, In Whom Cancer (of Any Grade) Was Detected
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.
Time frame: Up to 30 minutes
Population: Participants in whom Grade Group 5 was the highest grade of cancer that was detected by any biopsy approach.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acoustic Radiation Force Impulse (ARFI) | Number of Participants With Grade Group 5 Cancer, In Whom Cancer (of Any Grade) Was Detected | 1 Participants |
| MR-ultrasound Fusion | Number of Participants With Grade Group 5 Cancer, In Whom Cancer (of Any Grade) Was Detected | 1 Participants |
| Systematic Sampling | Number of Participants With Grade Group 5 Cancer, In Whom Cancer (of Any Grade) Was Detected | 1 Participants |