Phase 1
N=16
Assessing Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA-7.3) (18F) in Healthy Volunteers and Subjects With Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03995888 ↗Enrolled (actual)
16
Serious AEs
12.5%
Results posted
Feb 2026
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events as Classified by MedDRA — 2; 2; 1; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- rhPSMA-7.3 (18F) Injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Blue Earth Diagnostics
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events as Classified by MedDRA |
2; 2; 1; 2 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03995888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.