Imaging Study to Investigate Safety and Diagnostic Performance of rhPSMA 7.3 (18F) PET Ligand in Suspected Prostate Cancer Recurrence (SPOTLIGHT)

Study Overview
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Brief Summary
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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 suspected prostate cancer recurrence based on elevated Prostate-specific antigen (PSA) following prior therapy.

Official Title
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A Prospective, Phase 3, Multi Center, Single-arm, Imaging Study Investigating the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) PET Ligand in Men With Suspected Prostate Cancer Recurrence Based on Elevated PSA Following Prior Therapy.

Conditions
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Prostate Cancer

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is male and aged >18 years old. History of localized adenocarcinoma of the prostate with prior curative intent treatment. An elevated PSA, clinically suspicious for biochemically recurrent disease: Following Radical Prostatectomy: PSA >0.2 ng/mL Following Radiotherapy: nadir +2 ng/mL. Potentially eligible for salvage therapy with curative intent. 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 Androgen Deprivation Therapy (ADT).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Predictive Value (PPV) of rhPSMA-7.3 (18F) PET on a patient level using histopathology or confirmatory imaging as a Standard of Truth (SoT). | PPV (defined as true positive [TP]/{TP+false positive [FP]}) of rhPSMA-7.3 (18F) PET using histopathology or confirmatory imaging as a Standard of Truth (SoT). | 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
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Keywords Provided by Centre Hospitalier Valida
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Recurrent Prostate Cancer, Diagnostic, Prostate Specific Membrane Antigen (PSMA), Positron Emission Tomography (PET) Scan