Prostate Cancer
Conditions
Keywords
Recurrent Prostate Cancer, Diagnostic, Prostate Specific Membrane Antigen (PSMA), Positron Emission Tomography (PET) Scan
Brief summary
A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA 7.3 (18F) Positron Emission Tomography (PET) ligand in men with suspected prostate cancer recurrence based on elevated Prostate-specific antigen (PSA) following prior therapy.
Detailed description
The primary objective of this study was to assess the patient-level correct detection rate (CDR) and region-level positive predictive value (PPV) of rhPSMA-7.3 (18F) positron emission tomography (PET) for biochemical recurrence (BCR) of prostate cancer using histopathology or imaging as a standard of truth (SoT).
Interventions
Radioligand for PET CT scanning
DIAGNOSTIC_TESTPositron emission tomography scan
Imaging scan with radioligand
Sponsors
Parexel
Blue Earth Diagnostics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Positron Emission Tomography (PET) Imaging study
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is male and aged \>18 years old. 2. History of localized adenocarcinoma of the prostate with prior curative intent treatment. 3. An elevated PSA, clinically suspicious for biochemically recurrent disease: * Following Radical Prostatectomy: PSA \>0.2 ng/mL * Following Radiotherapy: nadir +2 ng/mL. 4. Potentially eligible for salvage therapy with curative intent.
Exclusion criteria
1. Patients who are planned to have an x-ray contrast agent or other PET radiotracer \<24 hours prior to the PET scan. 2. Patients currently receiving Androgen Deprivation Therapy (ADT).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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. |
| Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level | 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 | 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 |
| CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other | 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 | 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 |
| Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET in Patients Who Had Negative Baseline Conventional Imaging | 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 | 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. |
| Reader Kappa Statistics of rhPSMA7.3 (18F) Scan Interpretation by the Blinded Independent Readers | PET Scan on Day 1 | The Cohen's kappa statistic will be calculated to assess pairwise agreement between any 2 blinded independent readers |
| Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level | 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 | 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. |
| Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available | 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 | 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. |
| Percentage of Patients in Whom rhPSMA-7.3 (18F) PET Imaging Results Changed the Intended Patient Management (Major and Other Changes) | 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 | 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 |
Countries
Finland, Netherlands, United States
Participant flow
Recruitment details
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
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Single Arm 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 | 391 |
| Total | 391 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Biopsy ordered but area too small to biopsy | 1 |
| Overall Study | Biopsy ordered but not done | 1 |
| Overall Study | Death | 2 |
| Overall Study | It was previously confirmed | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Patient cancelled scheduled scans | 2 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Protocol Violation | 1 |
| 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
| Characteristic | Single Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 270 Participants |
| Age, Categorical Between 18 and 65 years | 121 Participants |
| Age, Continuous | 68.3 years STANDARD_DEVIATION 7.92 |
| Body Mass Index (BMI) | 28.68 Kg/m2 STANDARD_DEVIATION 4.74 |
| Duration of adjuvant treatment | 7.2 months STANDARD_DEVIATION 16.05 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 342 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 31 Participants |
| Gleason Grade Group (GGG) =1 | 39 participants |
| Gleason Grade Group (GGG) =2 | 104 participants |
| Gleason Grade Group (GGG) =3 | 116 participants |
| Gleason Grade Group (GGG) =4 | 41 participants |
| Gleason Grade Group (GGG) =5 | 64 participants |
| Gleason Grade Group (GGG) Missing | 27 participants |
| Race/Ethnicity, Customized Black or African American | 61 participants |
| Race/Ethnicity, Customized Not Reported | 21 participants |
| Race/Ethnicity, Customized Other | 14 participants |
| Race/Ethnicity, Customized White | 295 participants |
| Region of Enrollment Finland | 7 participants |
| Region of Enrollment Netherlands | 9 participants |
| Region of Enrollment United States | 375 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 391 Participants |
| Time since diagnosis of biochemical recurrence | 17.1 months STANDARD_DEVIATION 27.15 |
| Time since end of adjuvant treatment | 60.2 months STANDARD_DEVIATION 49.11 |
| Time since initial cancer diagnosis | 87.3 months STANDARD_DEVIATION 65.7 |
| Time since start of adjuvant treatment | 67.3 months STANDARD_DEVIATION 50.26 |
| TNM Stage M M0 | 243 participants |
| TNM Stage M M1 | 1 participants |
| TNM Stage M M1b | 1 participants |
| TNM Stage M Missing | 40 participants |
| TNM Stage M MX | 106 participants |
| TNM Stage N Missing | 28 participants |
| TNM Stage N N0 | 249 participants |
| TNM Stage N N1 | 53 participants |
| TNM Stage N NX | 61 participants |
| TNM (Tumor-Node-Metastasis) Stage T Missing | 24 participants |
| TNM (Tumor-Node-Metastasis) Stage T T1 | 4 participants |
| TNM (Tumor-Node-Metastasis) Stage T T1c | 54 participants |
| TNM (Tumor-Node-Metastasis) Stage T T2 | 52 participants |
| TNM (Tumor-Node-Metastasis) Stage T T2a | 15 participants |
| TNM (Tumor-Node-Metastasis) Stage T T2b | 10 participants |
| TNM (Tumor-Node-Metastasis) Stage T T2c | 63 participants |
| TNM (Tumor-Node-Metastasis) Stage T T3 | 10 participants |
| TNM (Tumor-Node-Metastasis) Stage T T3a | 82 participants |
| TNM (Tumor-Node-Metastasis) Stage T T3b | 68 participants |
| TNM (Tumor-Node-Metastasis) Stage T T4 | 2 participants |
| TNM (Tumor-Node-Metastasis) Stage T TX | 7 participants |
| Total Gleason Score =10 | 1 participants |
| Total Gleason Score ≤6 | 39 participants |
| Total Gleason Score =7 | 232 participants |
| Total Gleason Score =8 | 41 participants |
| Total Gleason Score =9 | 63 participants |
| Total Gleason Score Missing | 15 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 391 |
| other Total, other adverse events | 28 / 391 |
| serious Total, serious adverse events | 2 / 391 |
Outcome results
Primary
Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Efficacy Analysis Population (EAP) | 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 |
| Efficacy Analysis Population (EAP) | 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 |
| Efficacy Analysis Population (EAP) | 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 |
| Efficacy Analysis Population (EAP) | 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 |
| Efficacy Analysis Population (EAP) | 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 |
| Efficacy Analysis Population (EAP) | 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 |
Secondary
CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other
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
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Efficacy Analysis Population (EAP) | CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other | Central Reader 3 | 13.7 percentage |
| Efficacy Analysis Population (EAP) | CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other | Central Reader 2 | 13.1 percentage |
| Efficacy Analysis Population (EAP) | CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other | Central Reader 1 | 16.7 percentage |
| Histopathology Not Available as SoT | CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other | Central Reader 1 | 21.6 percentage |
| Histopathology Not Available as SoT | CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other | Central Reader 2 | 19.4 percentage |
| Histopathology Not Available as SoT | CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other | Central Reader 3 | 22.4 percentage |
| 1.0≤PSA<2.0 | CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other | Central Reader 1 | 29.2 percentage |
| 1.0≤PSA<2.0 | CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other | Central Reader 3 | 25.7 percentage |
| 1.0≤PSA<2.0 | CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other | Central Reader 2 | 30.6 percentage |
Secondary
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 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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Efficacy Analysis Population (EAP) | 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 |
| Efficacy Analysis Population (EAP) | 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 |
| Efficacy Analysis Population (EAP) | 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 |
| Efficacy Analysis Population (EAP) | 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 |
| Efficacy Analysis Population (EAP) | 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 |
| Efficacy Analysis Population (EAP) | 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 |
| Histopathology Not Available as SoT | 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 | 57.9 percentage |
| Histopathology Not Available as SoT | 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 | 49.2 percentage |
| Histopathology Not Available as SoT | 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 | 42.4 percentage |
| Histopathology Not Available as SoT | 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 | 45.5 percentage |
| Histopathology Not Available as SoT | 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 | 49.5 percentage |
| Histopathology Not Available as SoT | 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 | 46.5 percentage |
Secondary
Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET in Patients Who Had Negative Baseline Conventional Imaging
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Efficacy Analysis Population (EAP) | 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 |
| Efficacy Analysis Population (EAP) | 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 |
| Efficacy Analysis Population (EAP) | 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 |
| Efficacy Analysis Population (EAP) | 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 |
| Efficacy Analysis Population (EAP) | 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 |
| Efficacy Analysis Population (EAP) | 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 |
Secondary
Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level
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
Time frame: 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
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Efficacy Analysis Population (EAP) | Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 2 | 23.8 percentage |
| Efficacy Analysis Population (EAP) | Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 1 | 29.5 percentage |
| Efficacy Analysis Population (EAP) | Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 3 | 25.7 percentage |
| Histopathology Not Available as SoT | Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 2 | 41.3 percentage |
| Histopathology Not Available as SoT | Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 1 | 44.4 percentage |
| Histopathology Not Available as SoT | Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 3 | 46.0 percentage |
| 1.0≤PSA<2.0 | Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 2 | 65.1 percentage |
| 1.0≤PSA<2.0 | Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 1 | 65.1 percentage |
| 1.0≤PSA<2.0 | Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 3 | 62.8 percentage |
| 2.0≤PSA<5.0 | Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 3 | 69.3 percentage |
| 2.0≤PSA<5.0 | Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 1 | 72.7 percentage |
| 2.0≤PSA<5.0 | Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 2 | 70.5 percentage |
| 5.0≤PSA<10.0 | Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 1 | 61.1 percentage |
| 5.0≤PSA<10.0 | Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 2 | 58.3 percentage |
| 5.0≤PSA<10.0 | Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 3 | 58.3 percentage |
| PSA≥10.0 | Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 3 | 77.4 percentage |
| PSA≥10.0 | Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 1 | 80.7 percentage |
| PSA≥10.0 | Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 2 | 83.9 percentage |
Secondary
Percentage of Patients in Whom rhPSMA-7.3 (18F) PET Imaging Results Changed the Intended Patient Management (Major and Other Changes)
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
Time frame: 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
Population: Patients in the EAP who had documented patient management plans in the EDC before and after the rhPSMA-7.3 (18F) PET scan.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Efficacy Analysis Population (EAP) | 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 |
| Efficacy Analysis Population (EAP) | 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 |
| Efficacy Analysis Population (EAP) | 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 |
| Efficacy Analysis Population (EAP) | 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 |
| Efficacy Analysis Population (EAP) | 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 |
Secondary
Reader Kappa Statistics of rhPSMA7.3 (18F) Scan Interpretation by the Blinded Independent Readers
The Cohen's kappa statistic will be calculated to assess pairwise agreement between any 2 blinded independent readers
Time frame: PET Scan on Day 1
Population: Evaluable PET Scan Population (EPSP): All patients who received the rhPSMA-7.3 (18F) injection with a PET scan.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Efficacy Analysis Population (EAP) | Reader Kappa Statistics of rhPSMA7.3 (18F) Scan Interpretation by the Blinded Independent Readers | Central Reader 1 vs Reader 2 | 0.29 percentage |
| Efficacy Analysis Population (EAP) | Reader Kappa Statistics of rhPSMA7.3 (18F) Scan Interpretation by the Blinded Independent Readers | Central Reader 1 vs Reader 3 | 0.38 percentage |
| Efficacy Analysis Population (EAP) | Reader Kappa Statistics of rhPSMA7.3 (18F) Scan Interpretation by the Blinded Independent Readers | Central Reader 2 vs Reader 3 | 0.50 percentage |
Secondary
Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Efficacy Analysis Population (EAP) | 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 |
| Efficacy Analysis Population (EAP) | 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 |
| Efficacy Analysis Population (EAP) | 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 |
| Histopathology Not Available as SoT | Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available | Central Reader 2 | 57.9 percentage |
| Histopathology Not Available as SoT | Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available | Central Reader 1 | 42.4 percentage |
| Histopathology Not Available as SoT | Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available | Central Reader 3 | 49.5 percentage |
Secondary
Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Efficacy Analysis Population (EAP) | Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 3 | 34.5 percentage |
| Efficacy Analysis Population (EAP) | Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 2 | 50.8 percentage |
| Efficacy Analysis Population (EAP) | Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 1 | 29.1 percentage |
| Histopathology Not Available as SoT | Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 1 | 37.1 percentage |
| Histopathology Not Available as SoT | Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 2 | 51.8 percentage |
| Histopathology Not Available as SoT | Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 3 | 45.1 percentage |
| 1.0≤PSA<2.0 | Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 2 | 57.4 percentage |
| 1.0≤PSA<2.0 | Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 3 | 52.5 percentage |
| 1.0≤PSA<2.0 | Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 1 | 45.6 percentage |
| 2.0≤PSA<5.0 | Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 2 | 65.0 percentage |
| 2.0≤PSA<5.0 | Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 3 | 64.9 percentage |
| 2.0≤PSA<5.0 | Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 1 | 57.7 percentage |
| 5.0≤PSA<10.0 | Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 1 | 57.9 percentage |
| 5.0≤PSA<10.0 | Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 2 | 71.7 percentage |
| 5.0≤PSA<10.0 | Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 3 | 58.7 percentage |
| PSA≥10.0 | Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 1 | 59.6 percentage |
| PSA≥10.0 | Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 2 | 62.7 percentage |
| PSA≥10.0 | Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Central Reader 3 | 60.8 percentage |