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Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer

StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Aug 1, 2026 → Aug 1, 2027
See other at-risk trials from Thomas Jefferson University

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 1, 2026 to Aug 1, 2027
    • Start date: Jul 2026 to Oct 2026
    • Study completion pushed from Feb 2027 to Feb 2028
    v11
  2. Start date: Mar 15, 2026 to Jul 2026v10
  3. Start date: Nov 2025 to Mar 15, 2026v9
  4. Start date: Jul 2025 to Nov 2025v8
  5. Re-verified, no change to tracked fieldsv7
Show 5 earlier versionsHide 5 earlier versions
  1. Study description expanded, about 31 wordsv6
  2. Start date: Aug 2024 to Jul 2025v5
  3. Start date: Jun 2024 to Aug 2024v4
  4. Primary completion date: Aug 1, 2025 to Aug 1, 2026v3 Show 4 more changesShow less
    • Study sites: 1 to 2
    • Study completion date: Feb 2026 to Feb 2027
    • Collaborators expanded, about 11 words
    • Study title shortened, about 7 words
  5. Start date: Dec 2023 to Jun 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06024772
Lead Sponsor Thomas Jefferson University
Collaborators: Amsterdam UMC, location VUmc, Eindhoven University of Technology, Eigen, GE Healthcare
Conditions
(from sponsor)		 Prostate Carcinoma
Related terms Prostatic Neoplasms
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov