ARFI Imaging for Targeted Prostate Biopsy

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04607135
• Other study ID #: Pro00106093
• Status: Terminated
• Phase: N/A
• Start date: October 22, 2021
• Est. completion date: March 28, 2023

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: March 28, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• 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
• 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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chan DY. A 3-D Multiparametric Ultrasound Elasticity Imaging System for Targeted Prostate Biopsy Guidance [dissertation]. Durham (NC): Duke University; 2023.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants in Whom the Biopsy Approach Detected the Presence of Prostate Cancer (PCa) of Any Grade		Up to 30 minutes
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.	Up to 30 minutes
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.	Up to 30 minutes
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.	Up to 30 minutes
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.	Up to 30 minutes
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.	Up to 30 minutes
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.	Up to 30 minutes
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.	Up to 30 minutes
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.	Up to 30 minutes
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.	Up to 30 minutes
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.	Up to 30 minutes
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.	Up to 30 minutes
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.	Up to 30 minutes