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NCT04186845 · OUTCOME

Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available

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.

Measure
NUMBER
Unit
percentage
Interval / dispersion
95% Confidence Interval
Time frame
Conventional images 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

What was measured

Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions. The data are analysed by whether the patients have had histopathology as reference standard.

Analysis population: Efficacy Analysis Population (EAP): all patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm.

Groups in this outcome

Histopathology Available as SoT

Region-level PPV, Region-level 95% CIs were calculated via clustered binary data algorithm.

Histopathology Not Available as SoT

Region-level PPV, Region-level 95% CIs were calculated via clustered binary data algorithm.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Histopathology Available as SoT69
Histopathology Not Available as SoT297

Reported measurements

Central Reader 1
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Histopathology Available as SoT60.9Not reported52.069.8Not reported
Histopathology Not Available as SoT42.4Not reported37.747.0Not reported
Central Reader 2
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Histopathology Available as SoT67.0Not reported57.676.4Not reported
Histopathology Not Available as SoT57.9Not reported51.764.0Not reported
Central Reader 3
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Histopathology Available as SoT62.6Not reported53.571.8Not reported
Histopathology Not Available as SoT49.5Not reported43.855.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        52.0
        upper Limit
        69.8
        value
        60.9
      2. group Id
        OG001
        lower Limit
        37.7
        upper Limit
        47.0
        value
        42.4
    title
    Central Reader 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        57.6
        upper Limit
        76.4
        value
        67.0
      2. group Id
        OG001
        lower Limit
        51.7
        upper Limit
        64.0
        value
        57.9
    title
    Central Reader 2
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        53.5
        upper Limit
        71.8
        value
        62.6
      2. group Id
        OG001
        lower Limit
        43.8
        upper Limit
        55.3
        value
        49.5
    title
    Central Reader 3
denoms
  1. counts
    1. group Id
      OG000
      value
      69
    2. group Id
      OG001
      value
      297
    units
    Participants
description
Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions. The data are analysed by whether the patients have had histopathology as reference standard.
dispersion Type
95% Confidence Interval
groups
  1. description
    Region-level PPV, Region-level 95% CIs were calculated via clustered binary data algorithm.
    id
    OG000
    title
    Histopathology Available as SoT
  2. description
    Region-level PPV, Region-level 95% CIs were calculated via clustered binary data algorithm.
    id
    OG001
    title
    Histopathology Not Available as SoT
param Type
NUMBER
population Description
Efficacy Analysis Population (EAP): all patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm.
reporting Status
POSTED
time Frame
Conventional images 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
title
Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available
type
SECONDARY
unit Of Measure
percentage

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

Preserved source evidence · Not medical advice