Trial Outcomes & Findings for Imaging Study to Investigate Safety and Diagnostic Performance of 18F rhPSMA 7.3 PET Ligand in Suspected Prostate Cancer Recurrence (NCT NCT04186845)
NCT ID: NCT04186845
Last Updated: 2025-09-22
Results Overview
The CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any coexisting FP findings. When determining the region-level PPV, all rhPSMA7.3 (18F) PET-positive regions (maximum of three per patient) were categorized as TP or FP regions using histopathology or imaging.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
391 participants
Primary outcome timeframe
Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
Results posted on
2025-09-22
Participant Flow
This study was conducted from 04 May 20 (first patient, screening visit) and 12 Oct 21 (database lock), with last patient, last visit on 28 Apr 21. It was conducted at 28 activated study sites (27 recruited) in 3 countries. Of the 420 patients screened, 391 patients met all the study eligibility criteria
Baseline safety evaluations performed at screening (Visit 1) comprised vital signs and recording of any adverse events (AEs) from the time of informed consent. Conventional images collected within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
Participant milestones
| Measure |
Single Arm
All patients who were scheduled to receive the rhPSMA-7.3 (18F) injection having met the inclusion/exclusion criteria or who received the rhPSMA-7.3 (18F) injection.
|
|---|---|
|
Overall Study
STARTED
|
391
|
|
Overall Study
COMPLETED
|
378
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Single Arm
All patients who were scheduled to receive the rhPSMA-7.3 (18F) injection having met the inclusion/exclusion criteria or who received the rhPSMA-7.3 (18F) injection.
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Biopsy ordered but area too small to biopsy
|
1
|
|
Overall Study
Biopsy ordered but not done
|
1
|
|
Overall Study
It was previously confirmed
|
1
|
|
Overall Study
Patient cancelled scheduled scans
|
2
|
|
Overall Study
PSMA PET/CT scan show disease within previously Bx area
|
1
|
|
Overall Study
Subject refused confirmatory imaging
|
1
|
|
Overall Study
Too small to biopsy
|
1
|
Baseline Characteristics
Not all subjects had height and weight measured (eg only 337 subjects had height at baseline) - the trial was conducted during the Covid pandemic.
Baseline characteristics by cohort
| Measure |
Single Arm
n=391 Participants
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning
Positron emission tomography scan: Imaging scan with radioligand
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=391 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
121 Participants
n=391 Participants
|
|
Age, Categorical
>=65 years
|
270 Participants
n=391 Participants
|
|
Age, Continuous
|
68.3 years
STANDARD_DEVIATION 7.92 • n=391 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=391 Participants
|
|
Sex: Female, Male
Male
|
391 Participants
n=391 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=391 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
342 Participants
n=391 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
31 Participants
n=391 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
61 participants
n=391 Participants
|
|
Race/Ethnicity, Customized
White
|
295 participants
n=391 Participants
|
|
Race/Ethnicity, Customized
Other
|
14 participants
n=391 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
21 participants
n=391 Participants
|
|
Region of Enrollment
Netherlands
|
9 participants
n=391 Participants
|
|
Region of Enrollment
United States
|
375 participants
n=391 Participants
|
|
Region of Enrollment
Finland
|
7 participants
n=391 Participants
|
|
Total Gleason Score
≤6
|
39 participants
n=391 Participants
|
|
Total Gleason Score
=7
|
232 participants
n=391 Participants
|
|
Total Gleason Score
=8
|
41 participants
n=391 Participants
|
|
Total Gleason Score
=9
|
63 participants
n=391 Participants
|
|
Total Gleason Score
=10
|
1 participants
n=391 Participants
|
|
Total Gleason Score
Missing
|
15 participants
n=391 Participants
|
|
Gleason Grade Group (GGG)
=1
|
39 participants
n=391 Participants
|
|
Gleason Grade Group (GGG)
=2
|
104 participants
n=391 Participants
|
|
Gleason Grade Group (GGG)
=3
|
116 participants
n=391 Participants
|
|
Gleason Grade Group (GGG)
=4
|
41 participants
n=391 Participants
|
|
Gleason Grade Group (GGG)
=5
|
64 participants
n=391 Participants
|
|
Gleason Grade Group (GGG)
Missing
|
27 participants
n=391 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
T1
|
4 participants
n=391 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
T1c
|
54 participants
n=391 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
T2
|
52 participants
n=391 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
T2a
|
15 participants
n=391 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
T2b
|
10 participants
n=391 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
T2c
|
63 participants
n=391 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
T3
|
10 participants
n=391 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
T3a
|
82 participants
n=391 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
T3b
|
68 participants
n=391 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
T4
|
2 participants
n=391 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
TX
|
7 participants
n=391 Participants
|
|
TNM (Tumor-Node-Metastasis) Stage T
Missing
|
24 participants
n=391 Participants
|
|
TNM Stage N
N0
|
249 participants
n=391 Participants
|
|
TNM Stage N
N1
|
53 participants
n=391 Participants
|
|
TNM Stage N
NX
|
61 participants
n=391 Participants
|
|
TNM Stage N
Missing
|
28 participants
n=391 Participants
|
|
TNM Stage M
M0
|
243 participants
n=391 Participants
|
|
TNM Stage M
M1
|
1 participants
n=391 Participants
|
|
TNM Stage M
M1b
|
1 participants
n=391 Participants
|
|
TNM Stage M
MX
|
106 participants
n=391 Participants
|
|
TNM Stage M
Missing
|
40 participants
n=391 Participants
|
|
Body Mass Index (BMI)
|
28.68 Kg/m2
STANDARD_DEVIATION 4.740 • n=334 Participants • Not all subjects had height and weight measured (eg only 337 subjects had height at baseline) - the trial was conducted during the Covid pandemic.
|
|
Time since initial cancer diagnosis
|
87.3 months
STANDARD_DEVIATION 65.70 • n=389 Participants • Date of cancer diagnosis was not available for 2 participants.
|
|
Time since diagnosis of biochemical recurrence
|
17.1 months
STANDARD_DEVIATION 27.15 • n=390 Participants • Date of diagnosis of biochemical recurrence not available for all participants
|
|
Time since start of adjuvant treatment
|
67.3 months
STANDARD_DEVIATION 50.26 • n=190 Participants • Not all participants had adjuvant treatment and start date not always available for all participants who had adjuvant treatment.
|
|
Time since end of adjuvant treatment
|
60.2 months
STANDARD_DEVIATION 49.11 • n=192 Participants • Not all participants had adjuvant treatment and end date not always available for all participants who had adjuvant treatment.
|
|
Duration of adjuvant treatment
|
7.2 months
STANDARD_DEVIATION 16.05 • n=187 Participants • Not all participants had adjuvant treatment and start and end dates not always available for all participants who had adjuvant treatment in order to calculate duration.
|
PRIMARY outcome
Timeframe: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scanPopulation: Patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm.
The CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any coexisting FP findings. When determining the region-level PPV, all rhPSMA7.3 (18F) PET-positive regions (maximum of three per patient) were categorized as TP or FP regions using histopathology or imaging.
Outcome measures
| Measure |
Efficacy Analysis Population (EAP)
n=366 Participants
Patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm.
|
Histopathology Not Available as SoT
Patients without histopathology available as SoT
|
1.0≤PSA<2.0
1.0 ≤ PSA \< 2.0
|
2.0≤PSA<5.0
2.0 ≤ PSA \< 5.0
|
5.0≤PSA<10.0
5.0 ≤ PSA \< 10.0
|
PSA≥10.0
PSA ≥ 10.0
|
|---|---|---|---|---|---|---|
|
Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT
Patient-level CDR - Central Reader 1
|
54.1 percentage
Interval 48.8 to 59.3
|
—
|
—
|
—
|
—
|
—
|
|
Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT
Patient-level CDR - Central Reader 2
|
51.4 percentage
Interval 46.1 to 56.6
|
—
|
—
|
—
|
—
|
—
|
|
Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT
Patient-level CDR - Central Reader 3
|
51.6 percentage
Interval 46.4 to 56.9
|
—
|
—
|
—
|
—
|
—
|
|
Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT
Region-level PPV - Central Reader 1
|
46.2 percentage
Interval 42.0 to 50.3
|
—
|
—
|
—
|
—
|
—
|
|
Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT
Region-level PPV - Central Reader 2
|
60.3 percentage
Interval 55.1 to 65.5
|
—
|
—
|
—
|
—
|
—
|
|
Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT
Region-level PPV - Central Reader 3
|
52.6 percentage
Interval 47.6 to 57.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scanPopulation: Patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm.
Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions.
Outcome measures
| Measure |
Efficacy Analysis Population (EAP)
n=250 Participants
Patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm.
|
Histopathology Not Available as SoT
Patients without histopathology available as SoT
|
1.0≤PSA<2.0
1.0 ≤ PSA \< 2.0
|
2.0≤PSA<5.0
2.0 ≤ PSA \< 5.0
|
5.0≤PSA<10.0
5.0 ≤ PSA \< 10.0
|
PSA≥10.0
PSA ≥ 10.0
|
|---|---|---|---|---|---|---|
|
Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET in Patients Who Had Negative Baseline Conventional Imaging
Patient Level CDR - Central Reader 1
|
46.8 percentage
Interval 40.5 to 53.2
|
—
|
—
|
—
|
—
|
—
|
|
Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET in Patients Who Had Negative Baseline Conventional Imaging
Patient Level CDR - Central Reader 2
|
45.2 percentage
Interval 38.9 to 51.6
|
—
|
—
|
—
|
—
|
—
|
|
Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET in Patients Who Had Negative Baseline Conventional Imaging
Patient Level CDR - Central Reader 3
|
45.6 percentage
Interval 39.3 to 52.0
|
—
|
—
|
—
|
—
|
—
|
|
Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET in Patients Who Had Negative Baseline Conventional Imaging
Region-level PPV - Central Reader 1
|
39.7 percentage
Interval 34.6 to 44.9
|
—
|
—
|
—
|
—
|
—
|
|
Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET in Patients Who Had Negative Baseline Conventional Imaging
Region-level PPV - Central Reader 2
|
56.2 percentage
Interval 49.6 to 62.7
|
—
|
—
|
—
|
—
|
—
|
|
Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET in Patients Who Had Negative Baseline Conventional Imaging
Region-level PPV - Central Reader 3
|
46.8 percentage
Interval 40.7 to 52.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scanPopulation: Efficacy Analysis Population (EAP): all patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm.
Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions.
Outcome measures
| Measure |
Efficacy Analysis Population (EAP)
n=69 Participants
Patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm.
|
Histopathology Not Available as SoT
n=297 Participants
Patients without histopathology available as SoT
|
1.0≤PSA<2.0
1.0 ≤ PSA \< 2.0
|
2.0≤PSA<5.0
2.0 ≤ PSA \< 5.0
|
5.0≤PSA<10.0
5.0 ≤ PSA \< 10.0
|
PSA≥10.0
PSA ≥ 10.0
|
|---|---|---|---|---|---|---|
|
Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available
Patient-level CDR - Central Reader 1
|
75.4 percentage
Interval 63.5 to 84.9
|
49.2 percentage
Interval 43.3 to 55.0
|
—
|
—
|
—
|
—
|
|
Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available
Patient-level CDR - Central Reader 2
|
76.8 percentage
Interval 65.1 to 86.1
|
45.5 percentage
Interval 39.7 to 51.3
|
—
|
—
|
—
|
—
|
|
Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available
Patient-level CDR - Central Reader 3
|
73.9 percentage
Interval 61.9 to 89.7
|
46.5 percentage
Interval 40.7 to 52.3
|
—
|
—
|
—
|
—
|
|
Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available
Region-level PPV - Central Reader 1
|
60.9 percentage
Interval 52.0 to 69.8
|
42.4 percentage
Interval 37.7 to 47.0
|
—
|
—
|
—
|
—
|
|
Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available
Region-level PPV - Central Reader 2
|
67.0 percentage
Interval 57.6 to 76.4
|
57.9 percentage
Interval 51.7 to 64.0
|
—
|
—
|
—
|
—
|
|
Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available
Region-level PPV - Central Reader 3
|
62.6 percentage
Interval 53.5 to 71.8
|
49.5 percentage
Interval 43.8 to 55.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scanPopulation: Efficacy Analysis Population (EAP): all patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm, and with baseline PSA available
Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. The last PSA level before the PET scan will be used to stratify the patients
Outcome measures
| Measure |
Efficacy Analysis Population (EAP)
n=105 Participants
Patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm.
|
Histopathology Not Available as SoT
n=63 Participants
Patients without histopathology available as SoT
|
1.0≤PSA<2.0
n=43 Participants
1.0 ≤ PSA \< 2.0
|
2.0≤PSA<5.0
n=88 Participants
2.0 ≤ PSA \< 5.0
|
5.0≤PSA<10.0
n=36 Participants
5.0 ≤ PSA \< 10.0
|
PSA≥10.0
n=31 Participants
PSA ≥ 10.0
|
|---|---|---|---|---|---|---|
|
Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level
Central Reader 1
|
29.5 percentage
Interval 21.0 to 39.2
|
44.4 percentage
Interval 31.9 to 57.5
|
65.1 percentage
Interval 49.1 to 79.0
|
72.7 percentage
Interval 62.2 to 81.7
|
61.1 percentage
Interval 43.5 to 76.9
|
80.7 percentage
Interval 62.5 to 92.5
|
|
Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level
Central Reader 2
|
23.8 percentage
Interval 16.0 to 33.1
|
41.3 percentage
Interval 29.0 to 54.4
|
65.1 percentage
Interval 49.1 to 79.0
|
70.5 percentage
Interval 59.8 to 79.7
|
58.3 percentage
Interval 40.8 to 74.5
|
83.9 percentage
Interval 66.3 to 94.5
|
|
Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level
Central Reader 3
|
25.7 percentage
Interval 17.7 to 35.2
|
46.0 percentage
Interval 33.4 to 59.1
|
62.8 percentage
Interval 46.7 to 77.0
|
69.3 percentage
Interval 58.6 to 78.7
|
58.3 percentage
Interval 40.8 to 74.5
|
77.4 percentage
Interval 58.9 to 90.4
|
SECONDARY outcome
Timeframe: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scanPopulation: Efficacy Analysis Population (EAP): all patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm.
Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. The analysis was performed for each region and for each of the blinded independent readers
Outcome measures
| Measure |
Efficacy Analysis Population (EAP)
n=366 Participants
Patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm.
|
Histopathology Not Available as SoT
n=366 Participants
Patients without histopathology available as SoT
|
1.0≤PSA<2.0
n=366 Participants
1.0 ≤ PSA \< 2.0
|
2.0≤PSA<5.0
2.0 ≤ PSA \< 5.0
|
5.0≤PSA<10.0
5.0 ≤ PSA \< 10.0
|
PSA≥10.0
PSA ≥ 10.0
|
|---|---|---|---|---|---|---|
|
CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other
Central Reader 1
|
16.7 percentage
Interval 13.0 to 20.9
|
21.6 percentage
Interval 17.5 to 26.2
|
29.2 percentage
Interval 24.6 to 34.2
|
—
|
—
|
—
|
|
CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other
Central Reader 2
|
13.1 percentage
Interval 9.8 to 17.0
|
19.4 percentage
Interval 15.5 to 23.8
|
30.6 percentage
Interval 25.9 to 35.6
|
—
|
—
|
—
|
|
CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other
Central Reader 3
|
13.7 percentage
Interval 10.3 to 17.6
|
22.4 percentage
Interval 18.2 to 27.0
|
25.7 percentage
Interval 21.3 to 30.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scanPopulation: Patients in the EAP who had documented patient management plans in the EDC before and after the rhPSMA-7.3 (18F) PET scan.
This analysis used patients in the EAP who had documented patient management plans in the EDC before and after the rhPSMA-7.3 (18F) PET scan
Outcome measures
| Measure |
Efficacy Analysis Population (EAP)
n=167 Participants
Patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm.
|
Histopathology Not Available as SoT
Patients without histopathology available as SoT
|
1.0≤PSA<2.0
1.0 ≤ PSA \< 2.0
|
2.0≤PSA<5.0
2.0 ≤ PSA \< 5.0
|
5.0≤PSA<10.0
5.0 ≤ PSA \< 10.0
|
PSA≥10.0
PSA ≥ 10.0
|
|---|---|---|---|---|---|---|
|
Percentage of Patients in Whom rhPSMA-7.3 (18F) PET Imaging Results Changed the Intended Patient Management (Major and Other Changes)
Major Change
|
46.7 percentage
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients in Whom rhPSMA-7.3 (18F) PET Imaging Results Changed the Intended Patient Management (Major and Other Changes)
Minor Change
|
4.8 percentage
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients in Whom rhPSMA-7.3 (18F) PET Imaging Results Changed the Intended Patient Management (Major and Other Changes)
Additional Information Required
|
31.7 percentage
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients in Whom rhPSMA-7.3 (18F) PET Imaging Results Changed the Intended Patient Management (Major and Other Changes)
Pre-PSMA Plan Not Valid
|
10.2 percentage
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients in Whom rhPSMA-7.3 (18F) PET Imaging Results Changed the Intended Patient Management (Major and Other Changes)
No Change
|
6.6 percentage
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: PET Scan on Day 1Population: Evaluable PET Scan Population (EPSP): All patients who received the rhPSMA-7.3 (18F) injection with a PET scan.
The Cohen's kappa statistic will be calculated to assess pairwise agreement between any 2 blinded independent readers
Outcome measures
| Measure |
Efficacy Analysis Population (EAP)
n=389 Participants
Patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm.
|
Histopathology Not Available as SoT
Patients without histopathology available as SoT
|
1.0≤PSA<2.0
1.0 ≤ PSA \< 2.0
|
2.0≤PSA<5.0
2.0 ≤ PSA \< 5.0
|
5.0≤PSA<10.0
5.0 ≤ PSA \< 10.0
|
PSA≥10.0
PSA ≥ 10.0
|
|---|---|---|---|---|---|---|
|
Reader Kappa Statistics of rhPSMA7.3 (18F) Scan Interpretation by the Blinded Independent Readers
Central Reader 1 vs Reader 2
|
0.29 percentage
Interval 0.21 to 0.38
|
—
|
—
|
—
|
—
|
—
|
|
Reader Kappa Statistics of rhPSMA7.3 (18F) Scan Interpretation by the Blinded Independent Readers
Central Reader 1 vs Reader 3
|
0.38 percentage
Interval 0.25 to 0.51
|
—
|
—
|
—
|
—
|
—
|
|
Reader Kappa Statistics of rhPSMA7.3 (18F) Scan Interpretation by the Blinded Independent Readers
Central Reader 2 vs Reader 3
|
0.50 percentage
Interval 0.41 to 0.6
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scanPopulation: Efficacy Analysis Population (EAP): all patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm.
Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions.. The last PSA level before the rhPSMA-7.3 (18F) PET scan was used to stratify patients.
Outcome measures
| Measure |
Efficacy Analysis Population (EAP)
n=105 Participants
Patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm.
|
Histopathology Not Available as SoT
n=63 Participants
Patients without histopathology available as SoT
|
1.0≤PSA<2.0
n=43 Participants
1.0 ≤ PSA \< 2.0
|
2.0≤PSA<5.0
n=88 Participants
2.0 ≤ PSA \< 5.0
|
5.0≤PSA<10.0
n=36 Participants
5.0 ≤ PSA \< 10.0
|
PSA≥10.0
n=31 Participants
PSA ≥ 10.0
|
|---|---|---|---|---|---|---|
|
Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level
Central Reader 1
|
29.1 percentage
Interval 20.5 to 37.7
|
37.1 percentage
Interval 27.6 to 46.6
|
45.6 percentage
Interval 35.1 to 56.1
|
57.7 percentage
Interval 50.1 to 65.3
|
57.9 percentage
Interval 44.9 to 70.9
|
59.6 percentage
Interval 47.6 to 71.7
|
|
Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level
Central Reader 2
|
50.8 percentage
Interval 36.9 to 64.8
|
51.8 percentage
Interval 38.9 to 64.6
|
57.4 percentage
Interval 43.7 to 71.1
|
65.0 percentage
Interval 55.3 to 74.6
|
71.7 percentage
Interval 56.8 to 86.7
|
62.7 percentage
Interval 50.6 to 74.9
|
|
Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level
Central Reader 3
|
34.5 percentage
Interval 24.0 to 45.0
|
45.1 percentage
Interval 33.5 to 56.7
|
52.5 percentage
Interval 38.7 to 66.2
|
64.9 percentage
Interval 55.9 to 73.9
|
58.7 percentage
Interval 41.5 to 75.9
|
60.8 percentage
Interval 47.3 to 74.2
|
SECONDARY outcome
Timeframe: Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scanPopulation: Efficacy Analysis Population (EAP): all patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm.
Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions. The data are analysed by whether the patients have had histopathology as reference standard.
Outcome measures
| Measure |
Efficacy Analysis Population (EAP)
n=69 Participants
Patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm.
|
Histopathology Not Available as SoT
n=297 Participants
Patients without histopathology available as SoT
|
1.0≤PSA<2.0
1.0 ≤ PSA \< 2.0
|
2.0≤PSA<5.0
2.0 ≤ PSA \< 5.0
|
5.0≤PSA<10.0
5.0 ≤ PSA \< 10.0
|
PSA≥10.0
PSA ≥ 10.0
|
|---|---|---|---|---|---|---|
|
Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available
Central Reader 1
|
60.9 percentage
Interval 52.0 to 69.8
|
42.4 percentage
Interval 37.7 to 47.0
|
—
|
—
|
—
|
—
|
|
Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available
Central Reader 2
|
67.0 percentage
Interval 57.6 to 76.4
|
57.9 percentage
Interval 51.7 to 64.0
|
—
|
—
|
—
|
—
|
|
Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available
Central Reader 3
|
62.6 percentage
Interval 53.5 to 71.8
|
49.5 percentage
Interval 43.8 to 55.3
|
—
|
—
|
—
|
—
|
Adverse Events
Single Arm
Serious events: 2 serious events
Other events: 28 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Single Arm
n=391 participants at risk
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning
Positron emission tomography scan: Imaging scan with radioligand
|
|---|---|
|
General disorders
Sudden death
|
0.26%
1/391 • Number of events 1 • AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.26%
1/391 • Number of events 1 • AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
|
Other adverse events
| Measure |
Single Arm
n=391 participants at risk
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning
Positron emission tomography scan: Imaging scan with radioligand
|
|---|---|
|
Vascular disorders
Hypertension
|
1.8%
7/391 • Number of events 7 • AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
|
|
Vascular disorders
Flushing
|
0.26%
1/391 • Number of events 1 • AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
|
|
General disorders
Injection site reaction
|
0.51%
2/391 • Number of events 2 • AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
|
|
General disorders
Injection site discomfort
|
0.26%
1/391 • Number of events 1 • AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
|
|
General disorders
Fatigue
|
0.26%
1/391 • Number of events 1 • AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.26%
1/391 • Number of events 1 • AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
|
|
Psychiatric disorders
Anxiety
|
0.26%
1/391 • Number of events 1 • AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
|
|
Cardiac disorders
Tachycardia
|
0.26%
1/391 • Number of events 1 • AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
|
|
Nervous system disorders
Headache
|
0.51%
2/391 • Number of events 2 • AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
|
|
Nervous system disorders
Paraesthesia
|
0.26%
1/391 • Number of events 1 • AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
|
|
Nervous system disorders
Dizziness
|
0.26%
1/391 • Number of events 1 • AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
|
|
Eye disorders
Vision blurred
|
0.26%
1/391 • Number of events 1 • AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
|
|
Gastrointestinal disorders
Diarrhea
|
1.0%
4/391 • Number of events 4 • AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
|
|
Gastrointestinal disorders
Abdominal pain
|
0.26%
1/391 • Number of events 1 • AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
|
|
Gastrointestinal disorders
Nausea
|
0.26%
1/391 • Number of events 1 • AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.26%
1/391 • Number of events 1 • AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.26%
1/391 • Number of events 1 • AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.26%
1/391 • Number of events 1 • AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.26%
1/391 • Number of events 1 • AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.26%
1/391 • Number of events 1 • AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place