Diagnostic Accuracy and Performance of 18F-PSMA-1007

Completed

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: [18F]PSMA-1007

• Registration Number: NCT04986280
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

Whereas 18F-PSMA-1007 has rapidly established itself as a radiotracer for the investigation of prostate cancer, there are no studies confirming its diagnostic performance. The purpose of this study is to determine the diagnostic performance for this radiotracer.

Detailed Description

In this prospective, single-armed diagnostic imaging study men undergoing standard-of-care PSMA PET/CT using \[18F\]PSMA-1007 shall be studied. The primary objective is to confirm the positive predictive value (PPV) of this tracer at a patient-based level by recruiting until 53 patients with follow-up to a composite reference standard are available. Secondary outcomes shall include patient based rate of pathological-scans stratified by PSA, the PPV stratified by region , interrelate agreement, frequency of indeterminate lesions and the safety and tolerability of the examination.

Study Timeline

• Study First Submitted: 2021-04-12
• Study Start: 2021-07-13
• Study First Submitted QC: 2021-07-22
• Study First Posted: 2021-08-02
• Primary Completion: 2022-09-12
• Study Completion: 2024-03-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 174

Inclusion Criteria

• Adult Patients referred for investigation of recurrent PC by PSMA PET/CT.
• Patients with known biochemical recurrence of a histologically confirmed primary prostate cancer, defined as:

Post prostatectomy: two consecutive PSA > 0.2 ng/ml Post-radiotherapy: a rise of 2ng/mL > post-therapy nadir (ASTRO consensus definition)

• Male patients >18 years old
• PSA measured ± 4 weeks of the PSMA-PET/CT
• Patients willing and able to consent to the informed consent document

Exclusion Criteria

• Patients with ADT within 6 months prior to the PSMA-PET/CT
• Inability to provide informed, written consent
• Patients undergoing active treatment for a second non-prostatic malignancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single Arm	[18F]PSMA-1007	Arm 1 - All patients will undergo PET/CT with 18F-PSMA-1007

Primary Outcome Measures

Name	Time	Method
Primary objective: To confirm the PPV of the new tracer (patient-based PPV)	At one year follow up	The primary end point is the per patient PPV for the detection of PSMA-positive tumour lesions as confirmed by either a) histology or b) a composite reference standard of imaging and/or PSA fall following focal therapy in the absence of systemic therapy.

Secondary Outcome Measures

Name	Time	Method
• To determine the patient-based detection rate of pathologic scans (sensitivity) for the new tracer	Within one week of scan	Patient based detection (PET-positivity) rate (stratified by PSA value)
To explore the regional based PPV	At one year follow up	Region-based PPV (prostate bed, pelvic lymph nodes, extra-pelvic lymph nodes, extra-pelvic viscera and bone metastases)

Trial Locations

Locations (1)

Inselspital, Universitätsspital Bern; 🇨🇭 Bern, Switzerland