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NCT04186819 · OUTCOME

The Percentage of Patients Being Upstaged to N1 or M1 Disease. (Objective 6a)

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
Not reported
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

TP \[confirmed by SoT\] central BIE PET finding and negative conventional imaging finding from the local reading

Groups in this outcome

Upstaged to N1

Percentage of patient being upstaged to N1 (EEP)

Upstaged to M1

Percentage of patient being upstaged to M1 (EEP)

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

Analysis denominator · Participants

GroupSource count
Upstaged to N1352
Upstaged to M1352

Reported measurements

Central Reader 1
Values in percentage · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Upstaged to N15.1Not reportedNot reportedNot reportedNot reported
Upstaged to M18.2Not reportedNot reportedNot reportedNot reported
Central Reader 2
Values in percentage · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Upstaged to N14.3Not reportedNot reportedNot reportedNot reported
Upstaged to M112.2Not reportedNot reportedNot reportedNot reported
Central Reader 3
Values in percentage · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Upstaged to N13.7Not reportedNot reportedNot reportedNot reported
Upstaged to M18.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5.1
      2. group Id
        OG001
        value
        8.2
    title
    Central Reader 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4.3
      2. group Id
        OG001
        value
        12.2
    title
    Central Reader 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3.7
      2. group Id
        OG001
        value
        8.0
    title
    Central Reader 3
denoms
  1. counts
    1. group Id
      OG000
      value
      352
    2. group Id
      OG001
      value
      352
    units
    Participants
description
TP \[confirmed by SoT\] central BIE PET finding and negative conventional imaging finding from the local reading
groups
  1. description
    Percentage of patient being upstaged to N1 (EEP)
    id
    OG000
    title
    Upstaged to N1
  2. description
    Percentage of patient being upstaged to M1 (EEP)
    id
    OG001
    title
    Upstaged to M1
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
The Percentage of Patients Being Upstaged to N1 or M1 Disease. (Objective 6a)
type
SECONDARY
unit Of Measure
percentage

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

Preserved source evidence · Not medical advice