Assessing Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA-7.3) (18F) in Healthy Volunteers and Subjects With Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Drug: rhPSMA-7.3 (18F) Injection
- Registration Number
- NCT03995888
- Lead Sponsor
- Blue Earth Diagnostics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Healthy Volunteers
- Male and females 21-65 years.
- Clinically acceptable medical history
Key
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Healthy Volunteers rhPSMA-7.3 (18F) Injection Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan Patients rhPSMA-7.3 (18F) Injection Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
- Primary Outcome Measures
Name Time Method Number of participants with treatment-related adverse events as classified by MedDRA 1 month 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.
- Secondary Outcome Measures
Name Time Method In vivo 18F radioactivity in Prostate Cancer lesions 24 hours 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.
Cumulated activity exposure 24 hours Whole body radioactivity dose in MilliSievert/MegaBecquerel (mSv/MBq).
Dosimetry estimates 24 hours Dosimetry estimates in megagray/MegaBecquerel (mGy/MBq) by source region, including analysis of radioactivity in whole blood, plasma and excreted urine in healthy volunteers.
Uptake of rhPSMA-7.3 18F 24 hours Uptake of 18F-rhPSMA-7.3 injection visualized by PET imaging compared to histopathology in subjects with Prostate Cancer, where histopathology information is available.
Distribution of 18F-rhPSMA-7.3 24 hours Use of kinetic modelling data to investigate distribution of 18F-rhPSMA7.3 in subjects with Prostate Cancer.
% of radioactive parent compound present in plasma 24 hours 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.
Trial Locations
- Locations (1)
Clinical Research Services Turku - CRST Oy
🇫🇮Turku, Finland