Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT06024772
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Aug 1, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies)
    Patients undergo mp-MRI, receive Definity IV, and undergo transrectal mp-US and prostate biopsies on study.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Flemming Forsberg, PhD
[email protected]
215-955-4870

Find similar trials in Philadelphia, PA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Sidney Kimmel Cancer Center at Thomas Jefferson University· Philadelphia, PA

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