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

ABX advanced biochemical compounds GmbH29 sites in 6 countries380 target enrollmentJune 13, 2024

ConditionsProstate Cancer

Interventions[18F]PSMA-1007

Drugs[18F]PSMA-1007

Overview

Phase: Phase 3
Intervention: [18F]PSMA-1007
Conditions: Prostate Cancer
Sponsor: ABX advanced biochemical compounds GmbH
Enrollment: 380
Locations: 29
Primary Endpoint: 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
Status: Recruiting
Last Updated: 18 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

June 13, 2024

End Date

September 1, 2027

Last Updated

18 days ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

ABX advanced biochemical compounds GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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-
•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.

Arms & Interventions

[18F]PSMA-1007

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

Intervention: [18F]PSMA-1007

Outcomes

Primary Outcomes

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

Time Frame: 6 to 8 weeks post-surgery