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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

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: rhPSMA-7.3 (18F) Injection Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Positron Emission Tomography (PET) Imaging study
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : June 11, 2019
Actual Primary Completion Date : April 16, 2020
Actual Study Completion Date : April 16, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Healthy Volunteers
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
Drug: rhPSMA-7.3 (18F) Injection
Radioligand for PET CT scanning

Experimental: Patients
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
Drug: rhPSMA-7.3 (18F) Injection
Radioligand for PET CT scanning




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Cumulated activity exposure [ Time Frame: 24 hours ]
    Whole body radioactivity dose in MilliSievert/MegaBecquerel (mSv/MBq).

  3. 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.

  4. 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.

  5. 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.

  6. % 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995888


Locations
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Finland
Clinical Research Services Turku - CRST Oy
Turku, Finland, FI-20520
Sponsors and Collaborators
Blue Earth Diagnostics
Investigators
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Principal Investigator: Mika Scheinin Clinical Research Services Turku - CRST Oy
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Responsible Party: Blue Earth Diagnostics
ClinicalTrials.gov Identifier: NCT03995888    
Other Study ID Numbers: BED-PSMA-101
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases