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

Blue Earth Diagnostics

Status and phase: Completed; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: rhPSMA-7.3 (18F) Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT03995888

BED-PSMA-101

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

16 participants in 2 patient groups

Healthy Volunteers

Experimental group

Description:

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

Treatment:

Drug: rhPSMA-7.3 (18F) Injection

Patients

Experimental group

Description:

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

Treatment:

Drug: rhPSMA-7.3 (18F) Injection