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Not yet recruiting NCT06024772

Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer

Phase III Interventional Prostate Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ultiparametric Magnetic Resonance Imaging, Perflutren lipid microsphere, Transrectal Ultrasound, Biopsy of Prostate.
Who it may be relevant to
Registry conditions: Prostate Carcinoma. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prostate Cancer Diagnosis by Multiparametric Ultrasound (Clinical)

Overview

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.

Detailed 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.

Interventions

  • Procedure ultiparametric Magnetic Resonance Imaging
    Undergo mp-MRI
  • Drug Perflutren lipid microsphere
    Given IV
  • Procedure Transrectal Ultrasound
    Undergo transrectal mp-US
  • Procedure Biopsy of Prostate
    Undergo prostate biopsies

Primary outcome measures

  • Prostate cancer (PCa) detection rate of 3-dimensional (3D) multiparametric ultrasound (mp-US) combined with systematic biopsy [Time frame: Up to 2 years]
Secondary outcome measures (2)
  • PCa detection rate of 3D mp-US [Time frame: Up to 2 years]
  • 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 [Time frame: Up to 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia
Netherlands · 1 center
  • Amsterdam Medical Center — Amsterdam-Zuidoost

Identifiers

NCT: NCT06024772 · iRISID-2022-1191 · JT 20767

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗