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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995888
Recruitment Status : Completed
First Posted : June 24, 2019
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Blue Earth Diagnostics

Tracking Information
First Submitted Date  ICMJE June 18, 2019
First Posted Date  ICMJE June 24, 2019
Last Update Posted Date May 18, 2020
Actual Study Start Date  ICMJE June 11, 2019
Actual Primary Completion Date April 16, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
Number of participants with treatment-related adverse events as classified by MedDRA [ Time Frame: 1 month ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • Dosimetry estimates [ Time Frame: 24 hours ]
    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 [ Time Frame: 24 hours ]
    Whole body radioactivity dose in MilliSievert/MegaBecquerel (mSv/MBq).
  • Uptake of rhPSMA-7.3 18F [ Time Frame: 24 hours ]
    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 [ Time Frame: 24 hours ]
    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 [ Time Frame: 24 hours ]
    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 [ Time Frame: 24 hours ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA-7.3) (18F) in Healthy Volunteers and Subjects With Prostate Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Positron Emission Tomography (PET) Imaging study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Drug: rhPSMA-7.3 (18F) Injection
Radioligand for PET CT scanning
Study Arms  ICMJE
  • Experimental: Healthy Volunteers
    Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
    Intervention: Drug: rhPSMA-7.3 (18F) Injection
  • Experimental: Patients
    Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
    Intervention: Drug: rhPSMA-7.3 (18F) Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2020)
16
Original Estimated Enrollment  ICMJE
 (submitted: June 21, 2019)
15
Actual Study Completion Date  ICMJE April 16, 2020
Actual Primary Completion Date April 16, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03995888
Other Study ID Numbers  ICMJE BED-PSMA-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Blue Earth Diagnostics
Study Sponsor  ICMJE Blue Earth Diagnostics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mika Scheinin Clinical Research Services Turku - CRST Oy
PRS Account Blue Earth Diagnostics
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP