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PSMA PET Additive Value for Prostate Cancer Diagnosis in Men With Negative/Equivocal MRI

Study acronym: PRIMARY2
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Re-verified, no change to tracked fieldsv5
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Mar 2027 to Dec 15, 2025
    • Study completion date: Mar 2028 to Aug 2027
    • Site details revised at 6 of 6 sites
    v4
  3. Study sites: 1 to 6
    • Eligibility criteria revised
    v3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Feb 2027 to Mar 2027
    • Study completion date: Feb 2028 to Mar 2028
    • Start date changed from estimate of Feb 2022 to Mar 2, 2022
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 clinical trial will evaluate PSMA PET additive value for significant prostate cancer (sPCa) diagnosis in men with negative/equivocal MRI
Trial Details
NCT Number NCT05154162
Lead Sponsor Peter MacCallum Cancer Centre, Australia
Collaborators: St Vincent's Hospital, Sydney
Conditions
(from sponsor)		 Prostate Cancer
Related terms Neoplasms, Prostatic Neoplasms
Enrollment 660 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov