Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04186845 · OUTCOME

Patient-level CDR and 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

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: 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

Patients with Histopathology available as SoT

Histopathology Not Available as SoT

Patients without histopathology available as SoT

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

Patient-level CDR - Central Reader 1
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Histopathology Available as SoT75.4Not reported63.584.9Not reported
Histopathology Not Available as SoT49.2Not reported43.355.0Not reported
Patient-level CDR - Central Reader 2
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Histopathology Available as SoT76.8Not reported65.186.1Not reported
Histopathology Not Available as SoT45.5Not reported39.751.3Not reported
Patient-level CDR - Central Reader 3
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Histopathology Available as SoT73.9Not reported61.989.7Not reported
Histopathology Not Available as SoT46.5Not reported40.752.3Not reported
Region-level PPV - 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
Region-level PPV - 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
Region-level PPV - 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
        63.5
        upper Limit
        84.9
        value
        75.4
      2. group Id
        OG001
        lower Limit
        43.3
        upper Limit
        55.0
        value
        49.2
    title
    Patient-level CDR - Central Reader 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        65.1
        upper Limit
        86.1
        value
        76.8
      2. group Id
        OG001
        lower Limit
        39.7
        upper Limit
        51.3
        value
        45.5
    title
    Patient-level CDR - Central Reader 2
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        61.9
        upper Limit
        89.7
        value
        73.9
      2. group Id
        OG001
        lower Limit
        40.7
        upper Limit
        52.3
        value
        46.5
    title
    Patient-level CDR - Central Reader 3
  4. 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
    Region-level PPV - Central Reader 1
  5. 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
    Region-level PPV - Central Reader 2
  6. 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
    Region-level PPV - Central Reader 3
denoms
  1. counts
    1. group Id
      OG000
      value
      69
    2. group Id
      OG001
      value
      297
    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 with Histopathology available as SoT
    id
    OG000
    title
    Histopathology Available as SoT
  2. description
    Patients without histopathology available as SoT
    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
Patient-level CDR and 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