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NCT04186845 · OUTCOME

CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other

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. The analysis was performed for each region and for each of the blinded independent readers

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

Prostate/ Prostate Bed

Prostate or prostate bed

Pelvic Lymph Nodes

Pelvic Lymph Nodes

Other (Extra-pelvic) Sites

Other (extra-pelvic) sites

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

Analysis denominator · Participants

GroupSource count
Prostate/ Prostate Bed366
Pelvic Lymph Nodes366
Other (Extra-pelvic) Sites366

Reported measurements

Central Reader 1
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Prostate/ Prostate Bed16.7Not reported13.020.9Not reported
Pelvic Lymph Nodes21.6Not reported17.526.2Not reported
Other (Extra-pelvic) Sites29.2Not reported24.634.2Not reported
Central Reader 2
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Prostate/ Prostate Bed13.1Not reported9.817.0Not reported
Pelvic Lymph Nodes19.4Not reported15.523.8Not reported
Other (Extra-pelvic) Sites30.6Not reported25.935.6Not reported
Central Reader 3
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Prostate/ Prostate Bed13.7Not reported10.317.6Not reported
Pelvic Lymph Nodes22.4Not reported18.227.0Not reported
Other (Extra-pelvic) Sites25.7Not reported21.330.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.0
        upper Limit
        20.9
        value
        16.7
      2. group Id
        OG001
        lower Limit
        17.5
        upper Limit
        26.2
        value
        21.6
      3. group Id
        OG002
        lower Limit
        24.6
        upper Limit
        34.2
        value
        29.2
    title
    Central Reader 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.8
        upper Limit
        17.0
        value
        13.1
      2. group Id
        OG001
        lower Limit
        15.5
        upper Limit
        23.8
        value
        19.4
      3. group Id
        OG002
        lower Limit
        25.9
        upper Limit
        35.6
        value
        30.6
    title
    Central Reader 2
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.3
        upper Limit
        17.6
        value
        13.7
      2. group Id
        OG001
        lower Limit
        18.2
        upper Limit
        27.0
        value
        22.4
      3. group Id
        OG002
        lower Limit
        21.3
        upper Limit
        30.5
        value
        25.7
    title
    Central Reader 3
denoms
  1. counts
    1. group Id
      OG000
      value
      366
    2. group Id
      OG001
      value
      366
    3. group Id
      OG002
      value
      366
    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. The analysis was performed for each region and for each of the blinded independent readers
dispersion Type
95% Confidence Interval
groups
  1. description
    Prostate or prostate bed
    id
    OG000
    title
    Prostate/ Prostate Bed
  2. description
    Pelvic Lymph Nodes
    id
    OG001
    title
    Pelvic Lymph Nodes
  3. description
    Other (extra-pelvic) sites
    id
    OG002
    title
    Other (Extra-pelvic) Sites
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
CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other
type
SECONDARY
unit Of Measure
percentage

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Preserved source evidence · Not medical advice