NCT04186845 · OUTCOME

Percentage of Patients in Whom rhPSMA-7.3 (18F) PET Imaging Results Changed the Intended Patient Management (Major and Other Changes)

Imaging Study to Investigate Safety and Diagnostic Performance of 18F rhPSMA 7.3 PET Ligand in Suspected Prostate Cancer Recurrence · Source last updated 2025-09-22

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 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan

What was measured

This analysis used patients in the EAP who had documented patient management plans in the EDC before and after the rhPSMA-7.3 (18F) PET scan

Analysis population: Patients in the EAP who had documented patient management plans in the EDC before and after the rhPSMA-7.3 (18F) PET scan.

Groups in this outcome

Change in Management Plan

Change in Management Plan for patients with both pre-PSMA and post-PSMA management plans

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
Change in Management Plan	167

Reported measurements

No Change

Values in percentage · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Change in Management Plan	6.6	Not reported	Not reported	Not reported	Not reported

Major Change

Values in percentage · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Change in Management Plan	46.7	Not reported	Not reported	Not reported	Not reported

Minor Change

Values in percentage · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Change in Management Plan	4.8	Not reported	Not reported	Not reported	Not reported

Additional Information Required

Values in percentage · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Change in Management Plan	31.7	Not reported	Not reported	Not reported	Not reported

Pre-PSMA Plan Not Valid

Values in percentage · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Change in Management Plan	10.2	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
6.6
title
No Change
categories
measurements
group Id
OG000
value
46.7
title
Major Change
categories
measurements
group Id
OG000
value
4.8
title
Minor Change
categories
measurements
group Id
OG000
value
31.7
title
Additional Information Required
categories
measurements
group Id
OG000
value
10.2
title
Pre-PSMA Plan Not Valid

denoms

counts
group Id
OG000
value
167
units
Participants

description

This analysis used patients in the EAP who had documented patient management plans in the EDC before and after the rhPSMA-7.3 (18F) PET scan

groups

description
Change in Management Plan for patients with both pre-PSMA and post-PSMA management plans
id
OG000
title
Change in Management Plan

param Type

NUMBER

population Description

Patients in the EAP who had documented patient management plans in the EDC before and after the rhPSMA-7.3 (18F) PET scan.

reporting Status

POSTED

time Frame

Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan

title

Percentage of Patients in Whom rhPSMA-7.3 (18F) PET Imaging Results Changed the Intended Patient Management (Major and Other Changes)

type

SECONDARY

unit Of Measure

percentage

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

Preserved source evidence · Not medical advice