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

NCT03995888 | Completed Phase 1 Results

• 1 other identifier: BED-PSMA-101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Healthy Volunteers

EXPERIMENTAL

Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan

Drug: rhPSMA-7.3 (18F) Injection

Patients

EXPERIMENTAL

Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan

Drug: rhPSMA-7.3 (18F) Injection

Interventions

rhPSMA-7.3 (18F) Injection DRUG

Radioligand for PET CT scanning

Healthy Volunteers; Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Received ionising radiation exposure from clinical trials or medical examinations or treatment in the last 12 months.
• Suffers from claustrophobia.
• Bilateral hip prostheses.
• Male 18-80 years.
• Histologically confirmed adenocarcinoma of the prostate
• Clinically acceptable medical history
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• 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.

Sponsors & Collaborators

• Blue Earth Diagnostics: lead

Study Sites (1)

Clinical Research Services Turku - CRST Oy

Turku, FI-20520, Finland

Location

Related Publications (1)

• 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.

  PMID: 33846844 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Head of R&D
• Organization: Blue Earth Diagnostics, Ltd.

matthew.miller@blueearthdx.com

+44 (0) 1865 784 186

Study Officials

• Mika Scheinin

  Clinical Research Services Turku - CRST Oy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Positron Emission Tomography (PET) Imaging study

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 24, 2019
• Study Start: June 11, 2019
• Primary Completion: April 16, 2020
• Study Completion: April 16, 2020
• Last Updated: February 12, 2026
• Results First Posted: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)