Diagnostic Accuracy and Performance of 18F-PSMA-1007

Study Overview
=================
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.

Official Title
-----------------
Diagnostic Accuracy and Performance of 18F-PSMA-1007 in the Detection of Recurrent Prostate Cancer - a Prospective, Single-arm Study

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: [18F]PSMA-1007


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single Arm<br>Arm 1 - All patients will undergo PET/CT with 18F-PSMA-1007 | Diagnostic Test: [18F]PSMA-1007<br>* PSMA PET/CT using the intervention.<br>* Other names: F-18-PSMA-1007;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary objective: To confirm the PPV of the new tracer (patient-based PPV) | 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. | At one year follow up | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PSMA, Recurrent prostate cancer, Diagnostic accuracy, 18F-PSMA-1007, [18F]PSMA-1007