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NCT06024772 | NOT YET RECRUITING | Prostate Carcinoma

Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer
Sponsor:

Thomas Jefferson University

Information provided by (Responsible Party):

Flemming Forsberg

Brief 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.

Condition or disease

Prostate Carcinoma

Intervention/treatment

ultiparametric Magnetic Resonance Imaging

Perflutren lipid microsphere

Transrectal Ultrasound

Biopsy of Prostate

Phase

PHASE3

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 300 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Prostate Cancer Diagnosis by Multiparametric Ultrasound (Clinical)
Actual Study Start Date : 2025-07
Estimated Primary Completion Date : 2026-08-01
Estimated Study Completion Date : 2027-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
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
Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer

Location Details

NCT06024772

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How to Participate

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Locations

Not yet recruiting

United States, Pennsylvania

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Not yet recruiting

Netherlands,

Amsterdam Medical Center

Amsterdam-Zuidoost, Netherlands,