Participant flow

Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer. · Source last updated 2025-02-26

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

groups

1. description

   Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning Positron Emission Tomography scan: imaging test with radioligand

   id

   FG000

   title

   Patients

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Opted for EBRT

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Opted SBRT

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Patient decided to have focal ablation and not surgery

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Physician Decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      RP Delayed

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Sponsor Decision: Outdated FU Timeline

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Subject declined for financial reasons

   10. reasons

       1. group Id

          FG000

          num Subjects

          1

       type

       The subject declined any biopsy or surgery due to COVID-19 pandemic

   11. reasons

       1. group Id

          FG000

          num Subjects

          2

       type

       The subject declined for any biopsy or other imaging

   12. reasons

       1. group Id

          FG000

          num Subjects

          2

       type

       The subject opted for other treatment option

   Show more (12 of 15)

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         356

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         336

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         20

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Baseline safety evaluations performed at screening (Visit 1) comprised vital signs, focused physical examination and recording of any adverse events (AEs) from the time of informed consent.

recruitment Details

This study was from 02 Mar 20 (first patient, screening visit) and 18 Feb 22 (database lock), with the last patient, last visit on 21 Jun 21. It was conducted at 34 activated study sites (31 recruited) in 4 countries. Of the 372 patients screened, 356 patients met all the study eligibility criteria. 16 patients were screen failures so not included

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice