Back to resultsAssessing Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA-7.3) (18F) in Healthy Volunteers and Subjects With Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
Finland
Study Type
Interventional
Intervention
rhPSMA-7.3 (18F) Injection
Sponsored by
About this trial
This is an interventional diagnostic trial for 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.
Sites / Locations
- Clinical Research Services Turku - CRST Oy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy Volunteers
Patients
Arm Description
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Cumulated activity exposure
Whole body radioactivity dose in MilliSievert/MegaBecquerel (mSv/MBq).
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.
Distribution of 18F-rhPSMA-7.3
Use of kinetic modelling data to investigate distribution of 18F-rhPSMA7.3 in subjects with Prostate Cancer.
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.
% 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03995888
Brief Title
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
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 11, 2019 (Actual)
Primary Completion Date
April 16, 2020 (Actual)
Study Completion Date
April 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Blue Earth Diagnostics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Positron Emission Tomography (PET) Imaging study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Volunteers
Arm Type
Experimental
Arm Description
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
Arm Title
Patients
Arm Type
Experimental
Arm Description
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
Intervention Type
Drug
Intervention Name(s)
rhPSMA-7.3 (18F) Injection
Intervention Description
Radioligand for PET CT scanning
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as classified by MedDRA
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Dosimetry estimates
Description
Dosimetry estimates in megagray/MegaBecquerel (mGy/MBq) by source region, including analysis of radioactivity in whole blood, plasma and excreted urine in healthy volunteers.
Time Frame
24 hours
Title
Cumulated activity exposure
Description
Whole body radioactivity dose in MilliSievert/MegaBecquerel (mSv/MBq).
Time Frame
24 hours
Title
Uptake of rhPSMA-7.3 18F
Description
Uptake of 18F-rhPSMA-7.3 injection visualized by PET imaging compared to histopathology in subjects with Prostate Cancer, where histopathology information is available.
Time Frame
24 hours
Title
Distribution of 18F-rhPSMA-7.3
Description
Use of kinetic modelling data to investigate distribution of 18F-rhPSMA7.3 in subjects with Prostate Cancer.
Time Frame
24 hours
Title
In vivo 18F radioactivity in Prostate Cancer lesions
Description
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.
Time Frame
24 hours
Title
% of radioactive parent compound present in plasma
Description
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.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mika Scheinin
Organizational Affiliation
Clinical Research Services Turku - CRST Oy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Services Turku - CRST Oy
City
Turku
ZIP/Postal Code
FI-20520
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33846844
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.
Results Reference
derived
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Assessing Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA-7.3) (18F) in Healthy Volunteers and Subjects With Prostate Cancer
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