Diagnostic Accuracy and Performance of 18F-PSMA-1007

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Prostate Cancer

Treatments: Diagnostic Test: [18F]PSMA-1007

Study type: Observational

Funder types: Other

Identifiers

NCT04986280

2020-01383

Details and patient eligibility

About

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.

Full 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.

Enrollment: 174 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

174 participants in 1 patient group

Single Arm

Description:

Arm 1 - All patients will undergo PET/CT with 18F-PSMA-1007

Treatment:

Diagnostic Test: [18F]PSMA-1007