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NCT04186845 · OUTCOME

Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT

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

The 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 coexisting FP findings. When determining the region-level PPV, all rhPSMA7.3 (18F) PET-positive regions (maximum of three per patient) were categorized as TP or FP regions using histopathology or imaging.

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)366

Reported measurements

Patient-level CDR - Central Reader 1
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Efficacy Analysis Population (EAP)54.1Not reported48.859.3Not reported
Patient-level CDR - Central Reader 2
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Efficacy Analysis Population (EAP)51.4Not reported46.156.6Not reported
Patient-level CDR - Central Reader 3
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Efficacy Analysis Population (EAP)51.6Not reported46.456.9Not reported
Region-level PPV - Central Reader 1
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Efficacy Analysis Population (EAP)46.2Not reported42.050.3Not reported
Region-level PPV - Central Reader 2
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Efficacy Analysis Population (EAP)60.3Not reported55.165.5Not reported
Region-level PPV - Central Reader 3
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Efficacy Analysis Population (EAP)52.6Not reported47.657.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        48.8
        upper Limit
        59.3
        value
        54.1
    title
    Patient-level CDR - Central Reader 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        46.1
        upper Limit
        56.6
        value
        51.4
    title
    Patient-level CDR - Central Reader 2
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        46.4
        upper Limit
        56.9
        value
        51.6
    title
    Patient-level CDR - Central Reader 3
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        42.0
        upper Limit
        50.3
        value
        46.2
    title
    Region-level PPV - Central Reader 1
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        55.1
        upper Limit
        65.5
        value
        60.3
    title
    Region-level PPV - Central Reader 2
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        47.6
        upper Limit
        57.5
        value
        52.6
    title
    Region-level PPV - Central Reader 3
denoms
  1. counts
    1. group Id
      OG000
      value
      366
    units
    Participants
description
The 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 coexisting FP findings. When determining the region-level PPV, all rhPSMA7.3 (18F) PET-positive regions (maximum of three per patient) were categorized as TP or FP regions using histopathology or imaging.
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 rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT
type
PRIMARY
unit Of Measure
percentage

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

Preserved source evidence · Not medical advice