Actively Recruiting

Phase 3
Age: 18Years +
MALE
NCT06122584

Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed Prostate Cancer

Led by ABX advanced biochemical compounds GmbH · Updated on 2026-04-14

380

Participants Needed

18

Research Sites

167 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study assess the Diagnostic Performance of \[18F\]PSMA-1007 PET/CT Imaging in Patients with Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer

CONDITIONS

Official Title

Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients aged 18 years or older
  • Able to understand study information and provide written informed consent
  • Newly diagnosed, biopsy-confirmed, clinically localized prostate adenocarcinoma
  • Planned for curative prostatectomy with extended pelvic lymph node dissection
  • High-risk disease as defined by NCCN guidelines, including ISUP grade group 4 or 5, clinical category T3a or higher, or serum PSA level over 20 ng/ml
  • Underwent conventional imaging (CT or MRI, and bone scan if needed) within 60 days before planned PET-CT
Not Eligible

You will not qualify if you...

  • Not suitable or unlikely to have radical prostatectomy with extensive pelvic lymph node dissection
  • Received any prior therapy (radiation, surgery, drug) for prostate cancer
  • Known contraindications or hypersensitivity to any component of [18F]PSMA-1007
  • Unable to have PET-CT scans due to weight, claustrophobia, or inability to stay still
  • Close relation to the investigation site staff, such as first-degree relative of an investigator
  • Receiving or scheduled to receive other investigational agents within 30 days of study
  • Previously enrolled in this trial
  • Prior PET imaging with any PSMA-avid product
  • Histological evidence of small-cell carcinoma of the prostate
  • Clinically unstable or requiring emergency treatment
  • Mental condition preventing understanding of the trial nature and consequences

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 18 locations

1

CHRU de Nancy

Nancy, France

Actively Recruiting

2

Carl Gustav Carus Faculty of Medicine, TUD Dresden

Dresden, Germany

Actively Recruiting

3

University Hospital Düsseldorf

Düsseldorf, Germany

Actively Recruiting

4

St. Antonius Hospital

Gronau, Germany

Actively Recruiting

5

University Hospital Hamburg-Eppendorf

Hamburg, Germany

Actively Recruiting

6

University Hospital Leipzig

Leipzig, Germany

Actively Recruiting

7

Klinikum rechts der Isar, TUM

München, Germany

Active, Not Recruiting

8

University Hospital Münster

Münster, Germany

Actively Recruiting

9

Universitätsmedizin Rostock

Rostock, Germany

Actively Recruiting

10

IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"

Meldola, Italy

Actively Recruiting

11

IRCCS Ospedale Sacro Cuore-Don Calabria

Verona, Italy

Actively Recruiting

12

The University of Osaka Hospital

Osaka, Japan

Actively Recruiting

13

National Cancer Center

Tokyo, Japan

Actively Recruiting

14

CWZ

Nijmegen, Netherlands

Actively Recruiting

15

Radboud UMC

Nijmegen, Netherlands

Actively Recruiting

16

Hospital Del Mar

Barcelona, Spain

Actively Recruiting

17

Hospital Vall d'Hebron

Barcelona, Spain

Actively Recruiting

18

Hospital Vithas Valencia 9 de Octubre

Valencia, Spain

Active, Not Recruiting

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Research Team

A

Alexander Hoepping, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed Prostate Cancer | DecenTrialz