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NCT04186845 · OUTCOME

Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET in Patients Who Had Negative Baseline Conventional Imaging

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

Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions.

Analysis population: 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

Efficacy Analysis Population (EAP)

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.

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

Analysis denominator · Participants

GroupSource count
Efficacy Analysis Population (EAP)250

Reported measurements

Patient Level CDR - Central Reader 1
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Efficacy Analysis Population (EAP)46.8Not reported40.553.2Not reported
Patient Level CDR - Central Reader 2
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Efficacy Analysis Population (EAP)45.2Not reported38.951.6Not reported
Patient Level CDR - Central Reader 3
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Efficacy Analysis Population (EAP)45.6Not reported39.352.0Not reported
Region-level PPV - Central Reader 1
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Efficacy Analysis Population (EAP)39.7Not reported34.644.9Not reported
Region-level PPV - Central Reader 2
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Efficacy Analysis Population (EAP)56.2Not reported49.662.7Not reported
Region-level PPV - Central Reader 3
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Efficacy Analysis Population (EAP)46.8Not reported40.752.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        40.5
        upper Limit
        53.2
        value
        46.8
    title
    Patient Level CDR - Central Reader 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        38.9
        upper Limit
        51.6
        value
        45.2
    title
    Patient Level CDR - Central Reader 2
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.3
        upper Limit
        52.0
        value
        45.6
    title
    Patient Level CDR - Central Reader 3
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        34.6
        upper Limit
        44.9
        value
        39.7
    title
    Region-level PPV - Central Reader 1
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        49.6
        upper Limit
        62.7
        value
        56.2
    title
    Region-level PPV - Central Reader 2
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        40.7
        upper Limit
        52.9
        value
        46.8
    title
    Region-level PPV - Central Reader 3
denoms
  1. counts
    1. group Id
      OG000
      value
      250
    units
    Participants
description
Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    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.
    id
    OG000
    title
    Efficacy Analysis Population (EAP)
param Type
NUMBER
population Description
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
Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET in Patients Who Had Negative Baseline Conventional Imaging
type
SECONDARY
unit Of Measure
percentage

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

Preserved source evidence · Not medical advice