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NCT04186819 · OUTCOME

NPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FN Patient is Defined as Having at Least One FN Region (Right or Left Pelvis), Regardless of Any Coexisting TN Findings (Objective 5)

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 analysis included patients in the EAP with rhPSMA-7.3 (18F) imaging where no LN metastases were detected and LN surgical pathology was available; where NPV=TN/(TN+FN).

Groups in this outcome

Efficacy Analysis Population (EAP)

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 Population (EAP)296

Reported measurements

Central Reader 1
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Efficacy Analysis Population (EAP)81.3Not reported76.385.7Not reported
Central Reader 2
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Efficacy Analysis Population (EAP)80.8Not reported75.885.2Not reported
Central Reader 3
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Efficacy Analysis Population (EAP)79.9Not reported74.884.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        76.3
        upper Limit
        85.7
        value
        81.3
    title
    Central Reader 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        75.8
        upper Limit
        85.2
        value
        80.8
    title
    Central Reader 2
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        74.8
        upper Limit
        84.4
        value
        79.9
    title
    Central Reader 3
denoms
  1. counts
    1. group Id
      OG000
      value
      296
    units
    Participants
description
This analysis included patients in the EAP with rhPSMA-7.3 (18F) imaging where no LN metastases were detected and LN surgical pathology was available; where NPV=TN/(TN+FN).
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 (EAP)
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
NPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FN Patient is Defined as Having at Least One FN Region (Right or Left Pelvis), Regardless of Any Coexisting TN Findings (Objective 5)
type
SECONDARY
unit Of Measure
percentage

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

Preserved source evidence · Not medical advice