NCT04186819 · OUTCOME

Patient-level PPV of rhPSMA-7.3 (18F) PET BIE for N1 and M1 Lesions Compared to Histopathology or Confirmatory Imaging (M1 Lesions Only) (Objective 3)

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 with rhPSMA-7.3 (18F) imaging and either N1 or M1 lesions detected, where PPV=TP/(TP+FP).

Groups in this outcome

Efficacy Analysis Population (EAP)

N1 lesions compared to histopathology

Extended Efficacy Population (EEP)

M1 lesions compared to histopathology or confirmatory imaging

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

Analysis denominator · Participants

Group	Source count
Efficacy Analysis Population (EAP)	296
Extended Efficacy Population (EEP)	352

Reported measurements

Central Reader 1

Values in percentage · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Efficacy Analysis Population (EAP)	56.8	Not reported	39.5	72.9	Not reported
Extended Efficacy Population (EEP)	62.5	Not reported	48.5	75.1	Not reported

Central Reader 2

Values in percentage · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Efficacy Analysis Population (EAP)	57.6	Not reported	39.2	74.5	Not reported
Extended Efficacy Population (EEP)	51.0	Not reported	40.7	61.3	Not reported

Central Reader 3

Values in percentage · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Efficacy Analysis Population (EAP)	69.6	Not reported	47.1	86.8	Not reported
Extended Efficacy Population (EEP)	57.1	Not reported	44.0	69.5	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
39.5
upper Limit
72.9
value
56.8
group Id
OG001
lower Limit
48.5
upper Limit
75.1
value
62.5
title
Central Reader 1
categories
measurements
group Id
OG000
lower Limit
39.2
upper Limit
74.5
value
57.6
group Id
OG001
lower Limit
40.7
upper Limit
61.3
value
51.0
title
Central Reader 2
categories
measurements
group Id
OG000
lower Limit
47.1
upper Limit
86.8
value
69.6
group Id
OG001
lower Limit
44.0
upper Limit
69.5
value
57.1
title
Central Reader 3

denoms

counts
group Id
OG000
value
296
group Id
OG001
value
352
units
Participants

description

This analysis included patients with rhPSMA-7.3 (18F) imaging and either N1 or M1 lesions detected, where PPV=TP/(TP+FP).

dispersion Type

95% Confidence Interval

groups

description
N1 lesions compared to histopathology
id
OG000
title
Efficacy Analysis Population (EAP)
description
M1 lesions compared to histopathology or confirmatory imaging
id
OG001
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

Patient-level PPV of rhPSMA-7.3 (18F) PET BIE for N1 and M1 Lesions Compared to Histopathology or Confirmatory Imaging (M1 Lesions Only) (Objective 3)

type

SECONDARY

unit Of Measure

percentage

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

Preserved source evidence · Not medical advice