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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Experimental | Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan |
|
| Patients | Experimental | Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhPSMA-7.3 (18F) Injection | Drug | Radioligand for PET CT scanning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent 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. | 1 month |
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Key Inclusion Criteria: Healthy Volunteers
Key Exclusion Criteria: Healthy Volunteers
Key Inclusion Criteria: Patients
Key Exclusion Criteria: Patients
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| Name | Affiliation | Role |
|---|---|---|
| Mika Scheinin | Clinical Research Services Turku - CRST Oy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Services Turku - CRST Oy | Turku | FI-20520 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33846844 | Derived | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Volunteers | Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning |
| FG001 | Prostate Cancer Cohort A | Subjects with unfavourable intermediate-risk or high-risk primary prostate cancer Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning |
| FG002 | Prostate Cancer Cohort B | Subjects with hormone-sensitive metastatic prostate cancer Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning |
| FG003 | Prostate Cancer Cohort C | Subjects with castration-resistant metastatic disease Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Volunteers | Healthy Volunteers Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning |
| BG001 | Prostate Cancer Cohort A |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent 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. | Participants who have received at least one dose of Flourine-18 radiohybrid prostate-specific membrane antigen-7,3. | Posted | Count of Participants | Participants | 1 month |
|
As specified in the Statistical Analysis Plan, results are presented as only those treatment-emergent adverse events which occurred up to 1 Month after the 18F administration
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Volunteers | Healthy Volunteers Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retention of urine | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of R&D | Blue Earth Diagnostics, Ltd. | +44 (0) 1865 784 186 | matthew.miller@blueearthdx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 25, 2019 | Oct 27, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 30, 2019 | Oct 27, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Positron Emission Tomography (PET) Imaging study
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Subjects with unfavourable intermediate-risk or high-risk primary prostate cancer
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning
| BG002 | Prostate Cancer Cohort B | Subjects with hormone-sensitive metastatic prostate cancer Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning |
| BG003 | Prostate Cancer Cohort C | Subjects with castration-resistant metastatic disease Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height (cm | Median | Full Range | Centimeters (cm) |
|
| Weight (kg) | Median | Full Range | Kilograms (kg) |
|
| Body Mass Index (kg/m2) | Median | Full Range | Kilograms/meters squared [kg^m2] |
|
| Eastern Cooperative Oncology Group (ECOG) | ECOG clinical gradings reported are described below. As grading number increases, participants are clinically considered as being less able to care for themselves, daily activity, and physical ability (walking, working, etc.). Grade 0: Fully active, able to carry on all pre-disease performance without restriction Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work | ECOG was not reported for those six participants in the 'Healthy Volunteers' cohort. Therefore, is entered as '0 participants analyzed'. | Number | participants |
|
| Prostate Cancer Cohort A |
Subjects with unfavourable intermediate-risk or high-risk primary prostate cancer Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning |
| OG002 | Prostate Cancer Cohort B | Subjects with hormone-sensitive metastatic prostate cancer Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning |
| OG003 | Prostate Cancer Cohort C | Subjects with castration-resistant metastatic disease Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | Prostate Cancer Cohort A | Subjects with unfavourable intermediate-risk or high-risk primary prostate cancer Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning | 0 | 3 | 1 | 3 | 1 | 3 |
| EG002 | Prostate Cancer Cohort B | Subjects with hormone-sensitive metastatic prostate cancer Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning | 0 | 3 | 0 | 3 | 1 | 3 |
| EG003 | Prostate Cancer Cohort C | Subjects with castration-resistant metastatic disease Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning | 0 | 4 | 1 | 4 | 1 | 4 |
| Neutropenic infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
|
| Hepatic lesion | Hepatobiliary disorders | MedDRA version 18.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA version 18.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
|