Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer (LIGHTHOUSE)

Study Overview
=================
Brief Summary
-----------------
A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA) 7.3 (18F) Positron Emission Tomography (PET) ligand in men with newly diagnosed prostate cancer.

Official Title
-----------------
A Prospective, Phase 3, Multi Center, Single-arm, Imaging Study Investigating the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) Positron Emission Tomography (PET) Ligand in Men With Newly Diagnosed Prostate Cancer

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

Intervention / Treatment
-----------------
* Drug: rhPSMA-7.3 (18F) Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is male and aged >18 years old. Histologically confirmed adenocarcinoma of the prostate. Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND). Exclusion Criteria: Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan. Patients currently receiving, or with a prior history of, Androgen Deprivation Therapy (ADT).

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Positron Emission Tomography (PET) Imaging study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan | Drug: rhPSMA-7.3 (18F) Injection<br>* Radioligand for PET CT scanning<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of rhPSMA-7.3 (18F) | Sensitivity of rhPSMA-7.3 (18F) PET for detecting pelvic Lymph Node (LN) metastases compared to surgical pathology on a patient level. At least one positive pelvic LN (N1) on the PET scan and one positive LN (N1) as determined by histopathology (pN1) on the same side of the pelvis (Left or Right) will be counted a True Positive at the patient level. | 90 days | 
| Specificity of rhPSMA-7.3 (18F) | Specificity of rhPSMA-7.3 (18F) PET for detecting pelvic Lymph Node (LN) metastases compared to surgical pathology on a patient level. At least one positive pelvic LN (N1) on the PET scan and one positive LN (N1) as determined by histopathology (pN1) on the same side of the pelvis (Left or Right) will be counted a True Positive at the patient level. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-reader agreement of rhPSMA-7.3 (18F) scan interpretation by blinded independent readers. | Kappa statistic for the agreement between blinded independent readers on the interpretation of rhPSMA-7.3 (18F) scans. | 90 days | 
| Intra-reader agreement of rhPSMA-7.3 (18F) scan interpretation by blinded independent readers. | Kappa statistic for the agreement within blinded independent readers on the interpretation of rhPSMA-7.3 (18F) scans. | 90 days | 
| Number of participants with treatment-related adverse events as classified by MedDRA | Safety will be assessed from data on the occurrence of one or more treatment-emergent Adverse Events from the time of intravenous administration of 18F-rhPSMA-7.3 throughout the study period. | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Positron Emission Tomography (PET) Scan, Primary Prostate Cancer, Diagnostic, Prostate Specific Membrane Antigen (PSMA)