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Clinical Trials in Germany / NCT06122584
Recruiting Phase 3

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

NCT06122584 · tracked via the Priya Life Science Germany tracker
Sponsor
ABX advanced biochemical compounds GmbH
Phase
Phase 3
Started
2024-06-13
Last updated
2026-04-14

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

[18F]PSMA-1007 →

[18F]PSMA-1007: Diagnostic radiopharmaceutical for PET scan

Study summary

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

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. The patient (male) is aged 18 years or above. 2. The patient is able to understand the information presented to him concerning the nature, scope, and consequences of the trial as set out in the information provided to the patient AND has provided written informed consent to participate. 3. The patient has newly diagnosed, biopsy-proven, clinically localized prostate adenocarcinoma, and curative prostatectomy with extended pelvic lymph node dissection is his preferred course of treatment. 4. The patient has at least high-risk disease as defined by the NCCN guidelines (version 1.2023). That is, the presence of any one or more of the following: * Overall ISUP grade group 4 or 5, * Clinical category T3a or greater, * Serum PSA level greater than 20 ng/ml. 5. The patient has undergone conventional imaging (CT or MRI, and bone scan if clinically indicated) to detect the presence of pelvic nodal involvement and bone or visceral metastases within 60 days of the planned PET-CT procedure. Exclusion Criteria: 1. Patients for whom radical prostatectomy is not clinically appropriate or the patient is otherwise unlikely to undergo radical prostatectomy with extensive pelvic lymph node dissection. 2. The patient has received any therapy - be it radiation, surgical or drug therapy - for his prostate cancer. 3. The patient has any contraindication(s) for and/or known hypersensitivity to any constituent(s) of \[18F\]PSMA-1007. 4. The patient is not able to have PET-CT scans (for example, because of weight, claustrophobia, or inability to lie still for the duration of the scan). 5. The patient is closely affiliated to the investigation site; e.g. is a first-degree relative of the investigator. 6. At the time of screening, the patient is receiving any other investigational agent(s), or he has received any such agent(s) within the previous 30 days, or he is scheduled to receive any such agent(s) in the period up to the planned date for the last study visit. 7. The patient has previously been enrolled in this trial. 8. The patient has previously undergone PET imaging with any PSMA-avid product. 9. The patient has histological evidence of small-cell carcinoma of the prostate. 10. The patient is clinically unstable or requires emergency treatment. 11. The patient has any mental condition rendering him incapable of understanding the nature, scope, and consequences of the trial as set out in the information given to the patient.

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
CHRU de Nancy Nancy France Recruiting
Carl Gustav Carus Faculty of Medicine, TUD Dresden Dresden Germany Recruiting
University Hospital Düsseldorf Düsseldorf Germany Recruiting
St. Antonius Hospital Gronau Germany Recruiting
University Hospital Hamburg-Eppendorf Hamburg Germany Recruiting
University Hospital Leipzig Leipzig Germany Recruiting
Klinikum rechts der Isar, TUM München Germany Active Not Recruiting
University Hospital Münster Münster Germany Recruiting
Universitätsmedizin Rostock Rostock Germany Recruiting
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" Meldola Italy Recruiting
IRCCS Ospedale Sacro Cuore-Don Calabria Verona Italy Recruiting
The University of Osaka Hospital Osaka Japan Recruiting
National Cancer Center Tokyo Japan Recruiting
CWZ Nijmegen Netherlands Recruiting
Radboud UMC Nijmegen Netherlands Recruiting
Hospital Del Mar Barcelona Spain Recruiting
Hospital Vall d'Hebron Barcelona Spain Recruiting
Hospital Vithas Valencia 9 de Octubre Valencia Spain Active Not Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06122584 on ClinicalTrials.gov ↗ ← All trials in Germany