Actively Recruiting
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
Eligibility Criteria
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
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
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
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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