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NCT04186819 · OUTCOME

Sensitivity

Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer. · Source last updated 2025-02-26

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 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration

What was measured

The primary objective of the study is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND.

Groups in this outcome

Efficacy Analysis Population

All patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and who underwent RP and PLND

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 Population70

Reported measurements

Central Reader 1
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Efficacy Analysis Population30Not reported19.642.1Not reported
Central Reader 2
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Efficacy Analysis Population27.1Not reported17.239.1Not reported
Central Reader 3
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Efficacy Analysis Population22.9Not reported13.734.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.6
        upper Limit
        42.1
        value
        30
    title
    Central Reader 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.2
        upper Limit
        39.1
        value
        27.1
    title
    Central Reader 2
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.7
        upper Limit
        34.4
        value
        22.9
    title
    Central Reader 3
denoms
  1. counts
    1. group Id
      OG000
      value
      70
    units
    Participants
description
The primary objective of the study is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND.
dispersion Type
95% Confidence Interval
groups
  1. description
    All patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and who underwent RP and PLND
    id
    OG000
    title
    Efficacy Analysis Population
param Type
NUMBER
reporting Status
POSTED
time Frame
Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration
title
Sensitivity
type
PRIMARY
unit Of Measure
percentage

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

Preserved source evidence · Not medical advice