Prostate Cancer
Conditions
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.
Interventions
Radioligand for PET CT scanning
Sponsors
Blue Earth Diagnostics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Positron Emission Tomography (PET) Imaging study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events as Classified by MedDRA | 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. |
Countries
Finland
Contacts
PRINCIPAL_INVESTIGATORMika Scheinin
Clinical Research Services Turku - CRST Oy
Participant flow
Recruitment details
This study was conducted between 11 June 2019 (first subject, screening visit) and 16 April 2020 (last subject, last visit) at a single site in Finland. Of the 24 potential subjects screened, 16 met all the study eligibility criteria (six healthy volunteers and 10 subjects with prostate cancer). Five subjects were considered screen failures and three subjects were not assigned to IMP as they were back-up subjects who were subsequently not required for PET imaging.
Pre-assignment details
Baseline safety evaluations performed at screening (visit 1) comprised of vital signs, urine analysis, blood sample collection, pregnancy testing, physical exam, and recording of any adverse events (AEs) from the time of informed consent. Pertinent medical history and concomitant medications were also captured.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 69 Years |
| Body Mass Index (kg/m2) | 27.70 Kilograms/meters squared [kg^m2] |
| Eastern Cooperative Oncology Group (ECOG) 0 | 3 participants |
| Eastern Cooperative Oncology Group (ECOG) 1 | 2 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height (cm | 174 Centimeters (cm) |
| Region of Enrollment Finland | 3 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 0 Participants |
| Weight (kg) | 79.40 Kilograms (kg) |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 3 | 0 / 3 | 0 / 4 |
| other Total, other adverse events | 2 / 6 | 1 / 3 | 1 / 3 | 1 / 4 |
| serious Total, serious adverse events | 0 / 6 | 1 / 3 | 0 / 3 | 1 / 4 |
Outcome results
None listed