Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer

Thomas Jefferson University

Status and phase

Begins enrollment in 1 month

Phase 3

Conditions

Prostate Carcinoma

Treatments

Procedure: ultiparametric Magnetic Resonance Imaging

Procedure: Biopsy of Prostate

Procedure: Transrectal Ultrasound

Drug: Perflutren lipid microsphere

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06024772

JT 20767 (Other Identifier)

iRISID-2022-1191

Details and patient eligibility

About

This phase III trial compares the use of contrast-enhanced multiparametric ultrasound (mp-US) to multiparametric magnetic resonance imaging (mp-MRI) for the diagnosis of clinically significant prostate cancer (PCa). A mp-US is a procedure in which a probe that sends out high-energy sound waves is inserted into the rectum. The sound waves are bounced off internal tissues or organs and make echoes. The echoes form a picture of body tissue called a sonogram. Perflutren lipid michrosphere (Definity) is a contrast agent that uses microbubbles to enhance ultrasound images of the prostate. Doctors hope to learn if the Definity-enhanced mp-US imaging technique can accurately direct targeted biopsy for the detection of clinically significant prostate cancer when compared to standard of care mp-MRI.

Full description

PRIMARY OBJECTIVE:

I. To demonstrate non-inferiority between the detection rate of clinically significant PCa with 3-dimensional (3D) mp-US + systematic biopsy compared to the detection rate of mp-MRI + systematic biopsy.

II. To compare the positive yield of targeted biopsy cores based on mp-US + systematic biopsy with targeted biopsy based on mp-MRI + systematic biopsy, for detection of clinically significant PCa.

SECONDARY OBJECTIVES:

I. To demonstrate non-inferiority of a biopsy approach utilizing targeted biopsy cores based on mp-US compared with targeted biopsy based on mp-MRI, for detection of clinically significant PCa.

II. To construct an optimal logistic regression model to predict the presence of clinically significant PCa based on the mp-US elements as well as the prostate specific antigen (PSA), PSA velocity and any other biological variables (e.g., age).

OUTLINE:

Patients undergo mp-MRI, receive Definity intravenously (IV), and undergo transrectal mp-US and prostate biopsies on study.

Enrollment

300 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject must be scheduled for a prostate biopsy, based on an elevated PSA (> 3.0ng/ml) per most recent National Comprehensive Cancer Network (NCCN) guidelines, elevated PSA velocity (> 0.75ng/ml/year), or abnormal digital rectal examination
Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate including the additional study biopsies
Subject must be a male at least 18 years of age when informed consent is obtained

Exclusion criteria

Participant in a clinical trial involving an investigational drug within the past 30 days
Patients with known or suspected hypersensitivity to perflutren, polyethylene glycol (PEG), or any other component of Definity
Previous treatment for prostate cancer, including hormone therapy
Clinically unstable, severely ill, or moribund as per treating physician