Trial Outcomes & Findings for Assessing Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA-7.3) (18F) in Healthy Volunteers and Subjects With Prostate Cancer (NCT NCT03995888)
NCT ID: NCT03995888
Last Updated: 2026-02-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
1 month
Results posted on
2026-02-12
Participant Flow
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.
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.
Participant milestones
| Measure |
Healthy Volunteers
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning
|
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
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
3
|
4
|
|
Overall Study
COMPLETED
|
6
|
3
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ECOG was not reported for those six participants in the 'Healthy Volunteers' cohort. Therefore, is entered as '0 participants analyzed'.
Baseline characteristics by cohort
| Measure |
Healthy Volunteers
n=6 Participants
Healthy Volunteers
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning
|
Prostate Cancer Cohort A
n=3 Participants
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
|
Prostate Cancer Cohort B
n=3 Participants
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
|
Prostate Cancer Cohort C
n=4 Participants
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
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62 Years
n=6 Participants
|
55 Years
n=3 Participants
|
69 Years
n=3 Participants
|
73 Years
n=4 Participants
|
64 Years
n=16 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=16 Participants
|
|
Region of Enrollment
Finland
|
6 participants
n=6 Participants
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
4 participants
n=4 Participants
|
16 participants
n=16 Participants
|
|
Height (cm
|
175.25 Centimeters (cm)
n=6 Participants
|
177.50 Centimeters (cm)
n=3 Participants
|
174 Centimeters (cm)
n=3 Participants
|
171.75 Centimeters (cm)
n=4 Participants
|
173.27 Centimeters (cm)
n=16 Participants
|
|
Weight (kg)
|
79.15 Kilograms (kg)
n=6 Participants
|
81.80 Kilograms (kg)
n=3 Participants
|
82.70 Kilograms (kg)
n=3 Participants
|
79.40 Kilograms (kg)
n=4 Participants
|
80.50 Kilograms (kg)
n=16 Participants
|
|
Body Mass Index (kg/m2)
|
25.25 Kilograms/meters squared [kg^m2]
n=6 Participants
|
27.70 Kilograms/meters squared [kg^m2]
n=3 Participants
|
26.50 Kilograms/meters squared [kg^m2]
n=3 Participants
|
28.45 Kilograms/meters squared [kg^m2]
n=4 Participants
|
27.05 Kilograms/meters squared [kg^m2]
n=16 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
0
|
—
|
3 participants
n=3 Participants • ECOG was not reported for those six participants in the 'Healthy Volunteers' cohort. Therefore, is entered as '0 participants analyzed'.
|
3 participants
n=3 Participants • ECOG was not reported for those six participants in the 'Healthy Volunteers' cohort. Therefore, is entered as '0 participants analyzed'.
|
2 participants
n=4 Participants • ECOG was not reported for those six participants in the 'Healthy Volunteers' cohort. Therefore, is entered as '0 participants analyzed'.
|
8 participants
n=10 Participants • ECOG was not reported for those six participants in the 'Healthy Volunteers' cohort. Therefore, is entered as '0 participants analyzed'.
|
|
Eastern Cooperative Oncology Group (ECOG)
1
|
—
|
0 participants
n=3 Participants • ECOG was not reported for those six participants in the 'Healthy Volunteers' cohort. Therefore, is entered as '0 participants analyzed'.
|
0 participants
n=3 Participants • ECOG was not reported for those six participants in the 'Healthy Volunteers' cohort. Therefore, is entered as '0 participants analyzed'.
|
2 participants
n=4 Participants • ECOG was not reported for those six participants in the 'Healthy Volunteers' cohort. Therefore, is entered as '0 participants analyzed'.
|
2 participants
n=10 Participants • ECOG was not reported for those six participants in the 'Healthy Volunteers' cohort. Therefore, is entered as '0 participants analyzed'.
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Participants who have received at least one dose of Flourine-18 radiohybrid prostate-specific membrane antigen-7,3.
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.
Outcome measures
| Measure |
Healthy Volunteers
n=6 Participants
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning
|
Prostate Cancer Cohort A
n=3 Participants
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
|
Prostate Cancer Cohort B
n=3 Participants
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
|
Prostate Cancer Cohort C
n=4 Participants
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
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events as Classified by MedDRA
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
Adverse Events
Healthy Volunteers
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Prostate Cancer Cohort A
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Prostate Cancer Cohort B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Prostate Cancer Cohort C
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Healthy Volunteers
n=6 participants at risk
Healthy Volunteers
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning
|
Prostate Cancer Cohort A
n=3 participants at risk
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
|
Prostate Cancer Cohort B
n=3 participants at risk
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
|
Prostate Cancer Cohort C
n=4 participants at risk
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
|
|---|---|---|---|---|
|
Renal and urinary disorders
Retention of urine
|
0.00%
0/6 • 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
|
33.3%
1/3 • Number of events 1 • 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
|
0.00%
0/3 • 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
|
0.00%
0/4 • 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
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/6 • 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
|
0.00%
0/3 • 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
|
0.00%
0/3 • 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
|
25.0%
1/4 • Number of events 1 • 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
|
Other adverse events
| Measure |
Healthy Volunteers
n=6 participants at risk
Healthy Volunteers
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning
|
Prostate Cancer Cohort A
n=3 participants at risk
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
|
Prostate Cancer Cohort B
n=3 participants at risk
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
|
Prostate Cancer Cohort C
n=4 participants at risk
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
|
|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/3 • 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
|
0.00%
0/3 • 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
|
0.00%
0/4 • 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
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • 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
|
33.3%
1/3 • Number of events 1 • 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
|
0.00%
0/3 • 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
|
0.00%
0/4 • 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
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/3 • 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
|
0.00%
0/3 • 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
|
0.00%
0/4 • 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
|
|
Hepatobiliary disorders
Hepatic lesion
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/3 • 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
|
0.00%
0/3 • 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
|
0.00%
0/4 • 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
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • 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
|
0.00%
0/3 • 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
|
0.00%
0/3 • 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
|
25.0%
1/4 • Number of events 1 • 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
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • 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
|
0.00%
0/3 • 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
|
33.3%
1/3 • Number of events 1 • 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
|
0.00%
0/4 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place