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NCT04186819 · OUTCOME

Verified Detection Rate (VDR) for M1 Lesions - Percentage of Patients in Whom rhPSMA-7.3 (18F) Imaging Detected at Least One Verified M1 Metastasis, as Determined by Central BIE and Confirmed by SoT (Biopsy or Imaging) (Objective 1)

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

This was a key secondary endpoint in this study and included patients in the EEP with rhPSMA-7.3 (18F) imaging.

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)352

Reported measurements

Central Reader 1
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extended Efficacy Population (EEP)9.9Not reported7.013.6Not reported
Central Reader 2
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extended Efficacy Population (EEP)14.2Not reported10.718.3Not reported
Central Reader 3
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Extended Efficacy Population (EEP)10.2Not reported7.313.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.0
        upper Limit
        13.6
        value
        9.9
    title
    Central Reader 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.7
        upper Limit
        18.3
        value
        14.2
    title
    Central Reader 2
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.3
        upper Limit
        13.9
        value
        10.2
    title
    Central Reader 3
denoms
  1. counts
    1. group Id
      OG000
      value
      352
    units
    Participants
description
This was a key secondary endpoint in this study and included patients in the EEP with rhPSMA-7.3 (18F) imaging.
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
Verified Detection Rate (VDR) for M1 Lesions - Percentage of Patients in Whom rhPSMA-7.3 (18F) Imaging Detected at Least One Verified M1 Metastasis, as Determined by Central BIE and Confirmed by SoT (Biopsy or Imaging) (Objective 1)
type
SECONDARY
unit Of Measure
percentage

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

Preserved source evidence · Not medical advice