ARFI Imaging for Targeted Prostate Biopsy

Not Applicable

Terminated

• Conditions: Prostate Cancer
• Interventions: Device: Ultrasound; Device: Acoustic radiation force impulse (ARFI)

• Registration Number: NCT04607135
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-10-22
• Study First Posted: 2020-10-29
• Study Start: 2021-10-22
• Primary Completion: 2023-03-28
• Study Completion: 2023-03-28
• Results First Submitted: 2023-11-14
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-04
• Results First Posted: 2024-01-05
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 34

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MR-ultrasound fusion	Ultrasound	Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.
Acoustic radiation force impulse (ARFI)	Acoustic radiation force impulse (ARFI)	Patients with suspected PCa who are scheduled to undergo an ultrasound fusion-MR prostate biopsy.

Primary Outcome Measures

Name	Time	Method
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 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.
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 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 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, 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.
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 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, 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 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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States