NCT04186819 · OUTCOME

The Percentage of Patients in Whom Planned RP Was Converted to EBRT. (Objective 6b)

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

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

Group	Source count
Extended Efficacy Population (EEP)	352

Reported measurements

Source class 1

Values in percentage · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Extended Efficacy Population (EEP)	2.6	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
2.6

denoms

counts
group Id
OG000
value
352
units
Participants

groups

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

The Percentage of Patients in Whom Planned RP Was Converted to EBRT. (Objective 6b)

type

SECONDARY

unit Of Measure

percentage

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

Preserved source evidence · Not medical advice