← Back to the studies fieldPERMANENT CTIS TRIAL DOSSIER

2022-501892-14-00

Evaluation of PSMA-PET and mpMRI in high-risk prostate cancer – using histopathologic validation

Public registry stateAuthorised

CLAIM BOUNDARY

This dossier documents a medicinal trial—not proof of efficacy.

Registration, authorisation of a trial application, trial start, result disclosure and marketing authorisation are different facts. The dossier claims neither clinical efficacy nor safety, deployment or causality.

CTIS record ≠ efficacy ≠ marketing authorisation

REGISTRY FACTS

What CTIS publishes about this trial

EUCT number: 2022-501892-14-00
Trial status: Authorised
Sponsor: not published
Trial region: EEA
Phase: 5
Trial category: 2
Low-intervention trial: no
Estimated EU start: 14 October 2024
Decision date: 25 March 2024
Published: 15 February 2025
Estimated end: 31 December 2031

EXACT AI EVIDENCE

The original text determines inclusion.

Terms count only in allowlisted public CTIS fields. Sponsor, medical condition, phase or a generic software reference alone is not AI evidence.

“The exploratory objective is to investigate the potential use of machine learning to predict tumour lesions properties from mpMRI and PSMA-PET”

Source field: authorizedApplication.authorizedPartI.trialDetails.trialInformation.trialObjective.secondaryObjectives[3].secondaryObjective
Matched term: machine learning

MEDICAL CONTEXT

Conditions and therapeutic areas

Reported medical conditions

Prostate cancer

Therapeutic areas

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]28
Diseases [C] - Neoplasms [C04]4
Diseases [C] - Male Urogenital Diseases [C12]12

COUNTRY TRACKS

Every country retains its own published state.

A status in one country is not transferred to another. Decision dates and status histories remain separate source facts.

Sweden

Authorised

First decision: 25 March 2024
Latest decision: 25 March 2024

25 March 2024Authorised
25 March 2024Authorised

TRIAL APPLICATIONS

Submission, decision and country state remain separate

INITIAL

Authorised

Trial status: Authorised
Submitted: 20 December 2023
Decided: 25 March 2024

Decisions25 March 2024 · Authorized

Country statusSweden · Authorised

SOURCE-DATED CHRONICLE

Official dates, not an efficacy narrative.

The chronicle sorts published CTIS events. i6eal observation times follow on a separate clock.

20 December 2023Application Submitted
Application IN · Authorised
25 March 2024Country Assessment
Sweden · Application IN · Authorized
25 March 2024Application Status
Application IN · Authorised
25 March 2024Country Decision
Sweden · Application IN · Authorized
23 July 2026Trial Status Observed
Authorised

Observed by i6eal

First observed: 23 Jul 2026, 13:19
Last observed: 23 Jul 2026, 15:03
Materially modified: 23 July 2026

RESULT DISCLOSURE

Disclosure is a separate registry fact.

No result disclosure is published in this projection. This means neither that results do not exist nor that a deadline has been missed.

PROVENANCE

From the dossier back to the official record

The public CTIS record remains authoritative. The i6eal files are a deterministic, bounded projection.

Open public CTIS record ↗Open CTIS retrieval source ↗Machine-readable dossier · JSON ↓Structured metadata · JSON-LD ↓

i6eal (2026): EU AI Studies Monitor, CTIS trial 2022-501892-14-00, data state 23 July 2026. https://i6eal.de/en/tools/ki-studienmonitor/studie/2022-501892-14-00/