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

NCT06122584 | Recruiting Phase 3 FDA Drug

• 1 other identifier: EAGLE-i
• Study Type: interventional
• Target: 380
• Locations: 6 countries
• Sites: 18

Brief 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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of [18F]PSMA-1007 PET/CT for the detection of pelvic nodal disease (N1) compared to histology as the standard of reference

  6 to 8 weeks post-surgery

Study Arms (1)

[18F]PSMA-1007

EXPERIMENTAL

Single intravenous administration of \[18F\]PSMA-1007 for Positron Emission Tomography (PET) scan

Drug: [18F]PSMA-1007

Interventions

[18F]PSMA-1007 DRUG

Diagnostic radiopharmaceutical for PET scan

[18F]PSMA-1007

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient (male) is aged 18 years or above.
• 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.
• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• The patient has received any therapy - be it radiation, surgical or drug therapy - for his prostate cancer.
• The patient has any contraindication(s) for and/or known hypersensitivity to any constituent(s) of \[18F\]PSMA-1007.
• 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).
• The patient is closely affiliated to the investigation site; e.g. is a first-degree relative of the investigator.
• 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.
• The patient has previously been enrolled in this trial.
• The patient has previously undergone PET imaging with any PSMA-avid product.
• The patient has histological evidence of small-cell carcinoma of the prostate.
• The patient is clinically unstable or requires emergency treatment.
• 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.

Sponsors & Collaborators

• ABX advanced biochemical compounds GmbH: lead

Study Sites (18)

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

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Alexander Hoepping, Dr.

CONTACT

+49 3528 4041 60; cd@abx.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 8, 2023
• Study Start: June 13, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

JP (2); DE (8); FR (1); IT (2); NL (2); ES (3)