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NCT04186819 · OUTCOME

Percentage of Patients With Negative Conventional Imaging for M1 Disease in Whom rhPSMA-7.3 (18F) PET Detected at Least One Verified M1 Metastasis, as Determined by Central BIE (Objective 2)

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

Patients counted in this variable were a subset of those in Point 1 above, where both the numerator and denominator were only counting patients with negative conventional imaging (according to investigator assessment) for M1 disease.

Groups in this outcome

Extended Efficacy Population (EEP)

all patients who received rhPSMA-7.3 (18F) injection followed by a PET scan. This population included M0 and M1 patients independent of performance of RP and PLND and was used for M1 related efficacy and Kappa statistics.

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

Analysis denominator · Participants

GroupSource count
Extended Efficacy Population (EEP)331

Reported measurements

Central Reader 1
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extended Efficacy Population (EEP)8.8Not reported5.912.3Not reported
Central Reader 2
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extended Efficacy Population (EEP)13.0Not reported9.617.1Not reported
Central Reader 3
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extended Efficacy Population (EEP)8.5Not reported5.712.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.9
        upper Limit
        12.3
        value
        8.8
    title
    Central Reader 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.6
        upper Limit
        17.1
        value
        13.0
    title
    Central Reader 2
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.7
        upper Limit
        12.0
        value
        8.5
    title
    Central Reader 3
denoms
  1. counts
    1. group Id
      OG000
      value
      331
    units
    Participants
description
Patients counted in this variable were a subset of those in Point 1 above, where both the numerator and denominator were only counting patients with negative conventional imaging (according to investigator assessment) for M1 disease.
dispersion Type
95% Confidence Interval
groups
  1. description
    all patients who received rhPSMA-7.3 (18F) injection followed by a PET scan. This population included M0 and M1 patients independent of performance of RP and PLND and was used for M1 related efficacy and Kappa statistics.
    id
    OG000
    title
    Extended Efficacy Population (EEP)
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
Percentage of Patients With Negative Conventional Imaging for M1 Disease in Whom rhPSMA-7.3 (18F) PET Detected at Least One Verified M1 Metastasis, as Determined by Central BIE (Objective 2)
type
SECONDARY
unit Of Measure
percentage

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

Preserved source evidence · Not medical advice