Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer

Prostate Carcinoma Clinical Trial

Official title:

Prostate Cancer Diagnosis by Multiparametric Ultrasound (Clinical)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06024772
• Other study ID #: iRISID-2022-1191
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2024
• Est. completion date: February 2027

Study information

• Verified date: March 2024
• Source: Thomas Jefferson University
• Contact: Flemming Forsberg, PhD
• Phone: 215-955-4870
• Email: Flemming.Forsberg[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: February 2027
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Procedure:
• ultiparametric Magnetic Resonance Imaging
Undergo mp-MRI

Drug:
• Perflutren lipid microsphere
Given IV

Procedure:
• Transrectal Ultrasound
Undergo transrectal mp-US
• Biopsy of Prostate
Undergo prostate biopsies

Locations

Country	Name	City	State
Netherlands	Amsterdam Medical Center	Amsterdam-Zuidoost
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
Thomas Jefferson University	Amsterdam UMC, location VUmc, Eigen, Eindhoven University of Technology, GE Healthcare

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate cancer (PCa) detection rate of 3-dimensional (3D) multiparametric ultrasound (mp-US) combined with systematic biopsy	Will compare PCa detection rate of 3D mp-US combined with systematic biopsy to detection rate of multiparametric magnetic resonance imaging (mp-MRI) combined with systematic biopsy. Will evaluate paired biopsy data for non-inferiority and superiority endpoints, comparing the detection rate of clinically significant PCa with mp-US + systematic biopsy to the detection rate of mp-MRI + systematic biopsy. This analysis will be repeated using both definitions of clinically significant PCa. Categorical data will be summarized as counts and percentages (or proportions) and continuous data will be summarized with descriptive statistics such as mean, standard deviation (SD), median, and range.	Up to 2 years
Secondary	PCa detection rate of 3D mp-US	Categorical data will be summarized as counts and percentages (or proportions) and continuous data will be summarized with descriptive statistics such as mean, SD, median, and range. Continuous data will be analyzed using t-tests, or log-rank tests if data are not normally distributed. Variance is expressed through 95% confidence intervals and a significance level of 5% with Bonferroni correction for multiple comparisons will be used to control the group-wise error of the study for individual comparisons.	Up to 2 years
Secondary	Accuracy of PCa detection by biopsy using the optimal logistical model based around mp-US compared to the optimal logistical model based around mp-MRI	Will evaluate the accuracty of the optimal logistic model combining the mp-US elements as well as the prostate specific antigen, prostate specific antigen velocity and other biological variables.	Up to 2 years