Assessing Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA-7.3) (18F) in Healthy Volunteers and Subjects With Prostate Cancer

Study Overview
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Brief Summary
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A Phase 1, Open-label Study to Assess Safety, Biodistribution, and Internal Radiation Dosimetry of rhPSMA-7.3 (18F) Injection in Healthy Volunteers, and to Assess Safety and Investigate the Imaging Characteristics in Subjects With Prostate Cancer.

Official Title
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A Phase 1, Open-label Study to Assess Safety, Biodistribution, and Internal Radiation Dosimetry of rhPSMA-7.3 (18F) Injection in Healthy Volunteers, and to Assess Safety and Investigate the Imaging Characteristics in Subjects With Prostate Cancer

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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Key Inclusion Criteria: Healthy Volunteers Male and females 21-65 years. Clinically acceptable medical history Key Exclusion Criteria: Healthy Volunteers Received ionising radiation exposure from clinical trials or medical examinations or treatment in the last 12 months. Suffers from claustrophobia. Bilateral hip prostheses. Key Inclusion Criteria: Patients Male 18-80 years. Histologically confirmed adenocarcinoma of the prostate Clinically acceptable medical history Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Key Exclusion Criteria: Patients Biopsy 28 days prior to enrollment. Extensive metastatic disease. Underlying disease which might confound interpretation. Bilateral hip prostheses. High energy (>300 Kiloelectron Volt (keV)) gamma-emitting radioisotope administered within five physical half-lives, or any intravenous iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days prior to study drug administration. X-ray contrast agent (<24 hr for intravenous agents and <5 days for oral agents). History of claustrophobia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Positron Emission Tomography (PET) Imaging study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Volunteers<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>|
| 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 |
| --- | --- | --- |
| 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, and changes in serum biochemistry, hematology, coagulation, urinalysis, vital signs, Electrocardiogram (ECG), injection site status, and physical examination findings. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosimetry estimates | Dosimetry estimates in megagray/MegaBecquerel (mGy/MBq) by source region, including analysis of radioactivity in whole blood, plasma and excreted urine in healthy volunteers. | 24 hours | 
| Cumulated activity exposure | Whole body radioactivity dose in MilliSievert/MegaBecquerel (mSv/MBq). | 24 hours | 
| Uptake of rhPSMA-7.3 18F | Uptake of 18F-rhPSMA-7.3 injection visualized by PET imaging compared to histopathology in subjects with Prostate Cancer, where histopathology information is available. | 24 hours | 
| Distribution of 18F-rhPSMA-7.3 | Use of kinetic modelling data to investigate distribution of 18F-rhPSMA7.3 in subjects with Prostate Cancer. | 24 hours | 
| In vivo 18F radioactivity in Prostate Cancer lesions | Use of kinetic modelling data to optimize the imaging protocol for future studies in subjects with Prostate Cancer, by estimating in vivo 18F radioactivity in Prostate Cancer lesions. | 24 hours | 
| % of radioactive parent compound present in plasma | Analysis of % of radioactive parent compound present in plasma over time in healthy volunteers and subjects with Prostate Cancer. Relative proportions of radioactive tracer metabolites will be monitored if detected in significant amounts in the radio-High Performance Liquid Chromatography (HPLC) analysis. | 24 hours |