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

Prostate Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03995888
• Other study ID #: BED-PSMA-101
• Status: Completed
• Phase: Phase 1
• Start date: June 11, 2019
• Est. completion date: April 16, 2020

Study information

• Verified date: May 2020
• Source: Blue Earth Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 16, 2020
• Est. primary completion date: April 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• rhPSMA-7.3 (18F) Injection
Radioligand for PET CT scanning

Locations

Country	Name	City	State
Finland	Clinical Research Services Turku - CRST Oy	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Blue Earth Diagnostics

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related 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	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
Secondary	Cumulated activity exposure	Whole body radioactivity dose in MilliSievert/MegaBecquerel (mSv/MBq).	24 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	% 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