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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: rhPSMA-7.3 (18F) Injection

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland, FI-20520
    • Clinical Research Services Turku - CRST Oy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria: Healthy Volunteers

1. Male and females 21-65 years.
2. Clinically acceptable medical history

Key Exclusion Criteria: Healthy Volunteers

1. Received ionising radiation exposure from clinical trials or medical examinations or treatment in the last 12 months.
2. Suffers from claustrophobia.
3. Bilateral hip prostheses.

Key Inclusion Criteria: Patients

1. Male 18-80 years.
2. Histologically confirmed adenocarcinoma of the prostate
3. Clinically acceptable medical history
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Key Exclusion Criteria: Patients

1. Biopsy 28 days prior to enrollment.
2. Extensive metastatic disease.
3. Underlying disease which might confound interpretation.
4. Bilateral hip prostheses.
5. 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.
6. X-ray contrast agent (<24 hr for intravenous agents and <5 days for oral agents).
7. History of claustrophobia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Volunteers; Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan	Drug: rhPSMA-7.3 (18F) Injection; Radioligand for PET CT scanning
Experimental: Patients; Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan	Drug: rhPSMA-7.3 (18F) Injection; Radioligand for PET CT scanning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-emergent 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

Collaborators and Investigators

• Sponsor: Blue Earth Diagnostics
• Investigators: Principal Investigator: Mika Scheinin, Clinical Research Services Turku - CRST Oy

Publications and helpful links

General Publications

• Malaspina S, Oikonen V, Kuisma A, Ettala O, Mattila K, Bostrom PJ, Minn H, Kalliokoski K, Postema EJ, Miller MP, Scheinin M. Kinetic analysis and optimisation of 18F-rhPSMA-7.3 PET imaging of prostate cancer. Eur J Nucl Med Mol Imaging. 2021 Oct;48(11):3723-3731. doi: 10.1007/s00259-021-05346-8. Epub 2021 Apr 12.

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2019
• Primary Completion (Actual): April 16, 2020
• Study Completion (Actual): April 16, 2020

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 21, 2019
• First Posted (Actual): June 24, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: BED-PSMA-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No