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Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer.

Study acronym: RF2021-1237227
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Phase: Not specified to Phase 2 Primary completion date changed from estimate of Jul 2025 to Mar 24, 2026 · Completion date: Jul 2026 to Apr 2027 · Site details revisedv5 Show 3 more changesShow less
    • Primary completion date changed from estimate of Jul 2025 to Mar 24, 2026
    • Completion date: Jul 2026 to Apr 2027
    • Site details revised
  2. Completion date: Jul 2025 to Jul 2026v4
  3. Primary completion date: Jul 2024 to Jul 2025v3
  4. Study arms: 0 to 1v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 project aims to evaluate the role of fully hybrid PET/MRI with 18FPSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa). Our main hypothesis is that adding 18F-PSMA PET to mpMRI prior to biopsy, will reduce the number of false negative findings, while at the same time, allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk, clinically indolent PCa.
Trial Details
NCT Number NCT06305390
Lead Sponsor IRCCS San Raffaele
Conditions Clinical Suspicion of Prostate Cancer
Enrollment 167 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov