RecruitingPhase 3NCT06122584

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

Prospective, Multi-Center Study to Assess the Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer


Sponsor

ABX advanced biochemical compounds GmbH

Enrollment

380 participants

Start Date

Jun 13, 2024

Study Type

INTERVENTIONAL

Conditions

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: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates a specialized type of PET scan — using a tracer called [18F]PSMA-1007 — to see whether it can more accurately detect whether prostate cancer has spread to nearby lymph nodes before surgery, compared to standard CT and MRI imaging. **You may be eligible if...** - You are a male patient 18 or older with newly diagnosed, biopsy-confirmed prostate cancer - Your cancer is classified as at least high-risk (grade group 4 or 5, or PSA above 20, or stage T3a or higher) - You are planning to have surgery (radical prostatectomy with full lymph node dissection) - You have completed standard imaging (CT or MRI) within the past 60 days **You may NOT be eligible if...** - You have already received any treatment for prostate cancer (surgery, radiation, or medication) - You have an allergy or contraindication to [18F]PSMA-1007 - You cannot tolerate a PET-CT scan (due to weight, claustrophobia, or inability to lie still) - You have previously had PSMA-targeted PET imaging Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[18F]PSMA-1007

Diagnostic radiopharmaceutical for PET scan


Locations(18)

CHRU de Nancy

Nancy, France

Carl Gustav Carus Faculty of Medicine, TUD Dresden

Dresden, Germany

University Hospital Düsseldorf

Düsseldorf, Germany

St. Antonius Hospital

Gronau, Germany

University Hospital Hamburg-Eppendorf

Hamburg, Germany

University Hospital Leipzig

Leipzig, Germany

Klinikum rechts der Isar, TUM

München, Germany

University Hospital Münster

Münster, Germany

Universitätsmedizin Rostock

Rostock, Germany

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

Meldola, Italy

IRCCS Ospedale Sacro Cuore-Don Calabria

Verona, Italy

The University of Osaka Hospital

Osaka, Japan

National Cancer Center

Tokyo, Japan

CWZ

Nijmegen, Netherlands

Radboud UMC

Nijmegen, Netherlands

Hospital Del Mar

Barcelona, Spain

Hospital Vall d'Hebron

Barcelona, Spain

Hospital Vithas Valencia 9 de Octubre

Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT06122584


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