ARFI Imaging for Targeted Prostate Biopsy

Duke University

Status: Terminated

Conditions: Prostate Cancer

Treatments: Device: Acoustic radiation force impulse (ARFI); Device: Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04607135

Pro00106093

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Acoustic radiation force impulse (ARFI)

Experimental group

Description:

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

Treatment:

Device: Acoustic radiation force impulse (ARFI)

MR-ultrasound fusion

Active Comparator group

Description:

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

Treatment:

Device: Ultrasound