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Completed

NCT Number: NCT03995888

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Research Services Turku - CRST Oy

Turku, FI-20520, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rhPSMA-7.3 (18F) Injection

Drug

Radioligand for PET CT scanning

Primary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events as Classified by MedDRA

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Blue Earth Diagnostics

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 24, 2019
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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