Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.

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

Acoustic radiation force impulse (ARFI)

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

Ultrasound

Thomas Polascik, MD

Kathryn Nightingale, PhD

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.

ARFI Imaging for Targeted Prostate Biopsy

Acoustic Radiation Force Impulse (ARFI) Imaging for Targeted Prostate Biopsy

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.

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.

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.

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.

Duke University

Each participant was to undergo all three types of biopsy.

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.

Acoustic Radiation Force Impulse (ARFI)

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.

MR-ultrasound Fusion

Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.

Systematic sampling is a probability sampling method in which a random sample, with a fixed periodic interval, is selected from a larger population.

Systematic Sampling

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.

Patients With Suspected PCa Who Are Scheduled to Undergo an Ultrasound Fusion-MR Prostate Biopsy

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Kathy Nightingale, Ph.D.

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.

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.

Number of Participants in Whom the Biopsy Approach Detected the Presence of Prostate Cancer (PCa) of Any Grade

Participants in whom cancer was detected by a given biopsy approach.

Length of Cancerous Tissue

Grade Group of Cancerous Tissue

Participants in whom cancer was detected by each biopsy approach.

Gleason Score

Participants in whom Grade Group 1 was the highest grade of cancer that was detected by any biopsy approach.

Number of Participants With Grade Group 1 Cancer, In Whom Cancer Was Detected

Participants in whom Grade Group 2 was the highest grade of cancer that was detected by any biopsy approach.

Number of Participants With Grade Group 2 Cancer, In Whom Cancer (of Any Grade) Was Detected

Number of Participants With Grade Group 2 Cancer, Graded as Grade Group 2

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.

Number of Participants With Grade Group 3 Cancer, In Whom Cancer (of Any Grade) Was Detected

Number of Participants With Grade Group 3 Cancer, Graded as Grade Group 3

Participants in whom Grade Group 4 was the highest grade of cancer that was detected by any biopsy approach.

Number of Participants With Grade Group 4 Cancer, In Whom Cancer (of Any Grade) Was Detected

Number of Participants With Grade Group 4 Cancer, Graded as Grade Group 4

Participants in whom Grade Group 5 was the highest grade of cancer that was detected by any biopsy approach.

Spots Global Cancer Trial Database for acoustic radiation force impulse (arfi)