Clinical trial NCT03995888: Assessing Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA-7.3) (18F) in Healthy Volunteers and Subjects With Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: Blue Earth Diagnostics
Sponsor class: INDUSTRY
First posted: 2019-06-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Positron Emission Tomography (PET) Imaging study
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as classified by MedDRA
timeFrame: 1 month
Secondary outcomes:
measure: Dosimetry estimates
timeFrame: 24 hours
measure: Cumulated activity exposure
timeFrame: 24 hours
measure: Uptake of rhPSMA-7.3 18F
timeFrame: 24 hours
measure: Distribution of 18F-rhPSMA-7.3
timeFrame: 24 hours
measure: In vivo 18F radioactivity in Prostate Cancer lesions
timeFrame: 24 hours
measure: % of radioactive parent compound present in plasma
timeFrame: 24 hours
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Clinical Research Services Turku - CRST Oy
Study officials:
affiliation: Clinical Research Services Turku - CRST Oy
name: Mika Scheinin
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.