Participant flow

Imaging Study to Investigate Safety and Diagnostic Performance of 18F rhPSMA 7.3 PET Ligand in Suspected Prostate Cancer Recurrence · Source last updated 2025-09-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   All patients who were scheduled to receive the rhPSMA-7.3 (18F) injection having met the inclusion/exclusion criteria or who received the rhPSMA-7.3 (18F) injection.

   id

   FG000

   title

   Single Arm

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Protocol Violation

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Biopsy ordered but area too small to biopsy

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Biopsy ordered but not done

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      It was previously confirmed

   8. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Patient cancelled scheduled scans

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      PSMA PET/CT scan show disease within previously Bx area

   10. reasons

       1. group Id

          FG000

          num Subjects

          1

       type

       Subject refused confirmatory imaging

   11. reasons

       1. group Id

          FG000

          num Subjects

          1

       type

       Too small to biopsy

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         391

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         378

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         13

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Baseline safety evaluations performed at screening (Visit 1) comprised vital signs and recording of any adverse events (AEs) from the time of informed consent. Conventional images collected within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan

recruitment Details

This study was conducted from 04 May 20 (first patient, screening visit) and 12 Oct 21 (database lock), with last patient, last visit on 28 Apr 21. It was conducted at 28 activated study sites (27 recruited) in 3 countries. Of the 420 patients screened, 391 patients met all the study eligibility criteria

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Preserved source evidence · Not medical advice