Prostate Cancer
Conditions
Keywords
Primary 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 Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA) 7.3 (18F) Positron Emission Tomography (PET) ligand in men with newly diagnosed prostate cancer.
Detailed description
Main objective is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central blinded image evaluation \[BIE\]) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during radical prostatectomy (RP) and pelvic lymph node dissection (PLND). At least one positive pelvic LN on PET (N1) and one positive lymph node (LN) as determined by histopathology (pN1) on the same side of the pelvis (left or right) will be deemed a True Positive (TP) at the patient level.
Interventions
Radioligand for PET CT scanning
DIAGNOSTIC_TESTPositron Emission Tomography scan
imaging test 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. Histologically confirmed adenocarcinoma of the prostate. 3. Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).
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, or with a prior history of, Androgen Deprivation Therapy (ADT).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specificity | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration | The primary objective of the study is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND. |
| Sensitivity | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration | The primary objective of the study is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-level PPV of rhPSMA-7.3 (18F) PET BIE for N1 and M1 Lesions Compared to Histopathology or Confirmatory Imaging (M1 Lesions Only) (Objective 3) | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration | This analysis included patients with rhPSMA-7.3 (18F) imaging and either N1 or M1 lesions detected, where PPV=TP/(TP+FP). |
| PPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FP Patient is Defined as Having at Least One FP Region (Right or Left Pelvis), Regardless of Any Coexisting TP Findings (Objective 4) | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration | This analysis included patients in the EAP where rhPSMA-7.3 (18F) imaging detected PLN metastasis. Regions where rhPSMA7.3 (18F) imaging detected no LN metastasis were not included (by definition of PPV), hence only TP and FP regions were considered. TPs were all patients with a surgical pathology confirmed positive region and without a FP region. FP patients were those patients with any rhPSMA7.3 (18F) PETpositive region with negative or no surgical pathology. |
| NPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FN Patient is Defined as Having at Least One FN Region (Right or Left Pelvis), Regardless of Any Coexisting TN Findings (Objective 5) | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration | This analysis included patients in the EAP with rhPSMA-7.3 (18F) imaging where no LN metastases were detected and LN surgical pathology was available; where NPV=TN/(TN+FN). |
| Verified Detection Rate (VDR) for M1 Lesions - Percentage of Patients in Whom rhPSMA-7.3 (18F) Imaging Detected at Least One Verified M1 Metastasis, as Determined by Central BIE and Confirmed by SoT (Biopsy or Imaging) (Objective 1) | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET. followed by treatment within 60 days post IMP administration | This was a key secondary endpoint in this study and included patients in the EEP with rhPSMA-7.3 (18F) imaging. |
| The Percentage of Patients in Whom Planned RP Was Converted to EBRT. (Objective 6b) | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration | — |
| Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7) | PET/CT scans on Day 1 | Pairwise agreement between any 2 of the 3 readers (Kappa statistic could not be calculated for 2 of the pairwise agreements), and within readers between the initial read and re-read (Kappa statistics could not be calculated for 2 of the within-reader agreements) |
| The Percentage of Patients Being Upstaged to N1 or M1 Disease. (Objective 6a) | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration | TP \[confirmed by SoT\] central BIE PET finding and negative conventional imaging finding from the local reading |
| Percentage of Patients With Negative Conventional Imaging for M1 Disease in Whom rhPSMA-7.3 (18F) PET Detected at Least One Verified M1 Metastasis, as Determined by Central BIE (Objective 2) | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration | Patients counted in this variable were a subset of those in Point 1 above, where both the numerator and denominator were only counting patients with negative conventional imaging (according to investigator assessment) for M1 disease. |
Countries
Finland, Germany, Netherlands, United States
Participant flow
Recruitment details
This study was from 02 Mar 20 (first patient, screening visit) and 18 Feb 22 (database lock), with the last patient, last visit on 21 Jun 21. It was conducted at 34 activated study sites (31 recruited) in 4 countries. Of the 372 patients screened, 356 patients met all the study eligibility criteria. 16 patients were screen failures so not included
Pre-assignment details
Baseline safety evaluations performed at screening (Visit 1) comprised vital signs, focused physical examination and recording of any adverse events (AEs) from the time of informed consent.
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 test with radioligand | 356 |
| Total | 356 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Opted for EBRT | 1 |
| Overall Study | Opted SBRT | 1 |
| Overall Study | Patient decided to have focal ablation and not surgery | 2 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Reason not specified | 1 |
| Overall Study | RP Delayed | 1 |
| Overall Study | Sponsor Decision: Outdated FU Timeline | 1 |
| Overall Study | Subject declined for financial reasons | 1 |
| Overall Study | The subject declined any biopsy or surgery due to COVID-19 pandemic | 1 |
| Overall Study | The subject declined for any biopsy or other imaging | 2 |
| Overall Study | The subject opted for other treatment option | 2 |
| Overall Study | The subject opted for other treatment options | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Continuous | 64.9 years STANDARD_DEVIATION 6.98 |
| Age, Customized < 65 years | 163 participants |
| Age, Customized ≥ 65 years | 193 participants |
| Baseline Risk Category High-risk or Veryhigh-risk | 241 participants |
| Baseline Risk Category Immediate-Risk | 115 participants |
| Body Mass Index | 28.20 Kg/m2 STANDARD_DEVIATION 4.341 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 311 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 28 Participants |
| Gleason Grade Group (GGG) =1 | 6 participants |
| Gleason Grade Group (GGG) =2 | 50 participants |
| Gleason Grade Group (GGG) =3 | 110 participants |
| Gleason Grade Group (GGG) =4 | 87 participants |
| Gleason Grade Group (GGG) =5 | 103 participants |
| Last PSA Measurement (ng/mL) | 15.090 ng/mL STANDARD_DEVIATION 18.245 |
| Prostate-specific antigen (PSA) Characterization (ng/mL) >10.0 | 158 participants |
| Prostate-specific antigen (PSA) Characterization (ng/mL) >1.0 to 2.0 | 2 participants |
| Prostate-specific antigen (PSA) Characterization (ng/mL) >2.0 to 5.0 | 62 participants |
| Prostate-specific antigen (PSA) Characterization (ng/mL) >5.0 to 10.0 | 134 participants |
| Race/Ethnicity, Customized Black or African American | 30 participants |
| Race/Ethnicity, Customized Not Reported | 33 participants |
| Race/Ethnicity, Customized Other | 4 participants |
| Race/Ethnicity, Customized White | 289 participants |
| Region of Enrollment Finland | 18 participants |
| Region of Enrollment Germany | 86 participants |
| Region of Enrollment Netherlands | 14 participants |
| Region of Enrollment United States | 238 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 356 Participants |
| Time since initial cancer diagnosis | 2.9 months STANDARD_DEVIATION 10.27 |
| Time since last PSA Measurement | 2.5 months STANDARD_DEVIATION 2.83 |
| TNM Stage M M0 | 290 participants |
| TNM Stage M M1 | 4 participants |
| TNM Stage M M1a | 1 participants |
| TNM Stage M M1b | 1 participants |
| TNM Stage M Missing | 12 participants |
| TNM Stage M MX | 48 participants |
| TNM Stage N Missing | 12 participants |
| TNM Stage N N0 | 284 participants |
| TNM Stage N N1 | 11 participants |
| TNM Stage N NX | 49 participants |
| TNM (Tumor-Node-Metastasis) Stage T Missing | 12 participants |
| TNM (Tumor-Node-Metastasis) Stage T T1 | 16 participants |
| TNM (Tumor-Node-Metastasis) Stage T T1a | 2 participants |
| TNM (Tumor-Node-Metastasis) Stage T T1c | 127 participants |
| TNM (Tumor-Node-Metastasis) Stage T T2 | 58 participants |
| TNM (Tumor-Node-Metastasis) Stage T T2a | 18 participants |
| TNM (Tumor-Node-Metastasis) Stage T T2b | 25 participants |
| TNM (Tumor-Node-Metastasis) Stage T T2c | 33 participants |
| TNM (Tumor-Node-Metastasis) Stage T T3 | 20 participants |
| TNM (Tumor-Node-Metastasis) Stage T T3a | 21 participants |
| TNM (Tumor-Node-Metastasis) Stage T T3b | 12 participants |
| TNM (Tumor-Node-Metastasis) Stage T T3c | 1 participants |
| TNM (Tumor-Node-Metastasis) Stage T T4 | 2 participants |
| TNM (Tumor-Node-Metastasis) Stage T TX | 9 participants |
| Total Gleason Score =10 | 6 participants |
| Total Gleason Score ≤ 6 | 6 participants |
| Total Gleason Score =7 | 160 participants |
| Total Gleason Score =8 | 87 participants |
| Total Gleason Score =9 | 97 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 356 |
| other Total, other adverse events | 28 / 356 |
| serious Total, serious adverse events | 0 / 356 |
Outcome results
Primary
Sensitivity
The primary objective of the study is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND.
Time frame: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Efficacy Analysis Population | Sensitivity | Central Reader 1 | 30 percentage |
| Efficacy Analysis Population | Sensitivity | Central Reader 2 | 27.1 percentage |
| Efficacy Analysis Population | Sensitivity | Central Reader 3 | 22.9 percentage |
Primary
Specificity
The primary objective of the study is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND.
Time frame: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Efficacy Analysis Population | Specificity | Central Reader 1 | 92.9 percentage |
| Efficacy Analysis Population | Specificity | Central Reader 2 | 93.8 percentage |
| Efficacy Analysis Population | Specificity | Central Reader 3 | 96.9 percentage |
Secondary
Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7)
Pairwise agreement between any 2 of the 3 readers (Kappa statistic could not be calculated for 2 of the pairwise agreements), and within readers between the initial read and re-read (Kappa statistics could not be calculated for 2 of the within-reader agreements)
Time frame: PET/CT scans on Day 1
Population: All patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Efficacy Analysis Population | Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7) | Agreement between reader 1 and reader 2 | 97.7 percentage |
| Efficacy Analysis Population | Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7) | Agreement between Reader 1 and Reader 3 | 95.2 percentage |
| Efficacy Analysis Population | Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7) | Agreement between Reader 2 and Reader 3 | 96.9 percentage |
| Efficacy Analysis Population | Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7) | Agreement between initial read and re-read in Reader 1 | 100 percentage |
| Efficacy Analysis Population | Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7) | Agreement between initial read and re-read in Reader 2 | 100 percentage |
| Efficacy Analysis Population | Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7) | Agreement between initial read and re-read in Reader 3 | 95.7 percentage |
Secondary
NPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FN Patient is Defined as Having at Least One FN Region (Right or Left Pelvis), Regardless of Any Coexisting TN Findings (Objective 5)
This analysis included patients in the EAP with rhPSMA-7.3 (18F) imaging where no LN metastases were detected and LN surgical pathology was available; where NPV=TN/(TN+FN).
Time frame: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Efficacy Analysis Population | NPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FN Patient is Defined as Having at Least One FN Region (Right or Left Pelvis), Regardless of Any Coexisting TN Findings (Objective 5) | Central Reader 1 | 81.3 percentage |
| Efficacy Analysis Population | NPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FN Patient is Defined as Having at Least One FN Region (Right or Left Pelvis), Regardless of Any Coexisting TN Findings (Objective 5) | Central Reader 2 | 80.8 percentage |
| Efficacy Analysis Population | NPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FN Patient is Defined as Having at Least One FN Region (Right or Left Pelvis), Regardless of Any Coexisting TN Findings (Objective 5) | Central Reader 3 | 79.9 percentage |
Secondary
Patient-level PPV of rhPSMA-7.3 (18F) PET BIE for N1 and M1 Lesions Compared to Histopathology or Confirmatory Imaging (M1 Lesions Only) (Objective 3)
This analysis included patients with rhPSMA-7.3 (18F) imaging and either N1 or M1 lesions detected, where PPV=TP/(TP+FP).
Time frame: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Efficacy Analysis Population | Patient-level PPV of rhPSMA-7.3 (18F) PET BIE for N1 and M1 Lesions Compared to Histopathology or Confirmatory Imaging (M1 Lesions Only) (Objective 3) | Central Reader 1 | 56.8 percentage |
| Efficacy Analysis Population | Patient-level PPV of rhPSMA-7.3 (18F) PET BIE for N1 and M1 Lesions Compared to Histopathology or Confirmatory Imaging (M1 Lesions Only) (Objective 3) | Central Reader 2 | 57.6 percentage |
| Efficacy Analysis Population | Patient-level PPV of rhPSMA-7.3 (18F) PET BIE for N1 and M1 Lesions Compared to Histopathology or Confirmatory Imaging (M1 Lesions Only) (Objective 3) | Central Reader 3 | 69.6 percentage |
| Extended Efficacy Population (EEP) | Patient-level PPV of rhPSMA-7.3 (18F) PET BIE for N1 and M1 Lesions Compared to Histopathology or Confirmatory Imaging (M1 Lesions Only) (Objective 3) | Central Reader 2 | 51.0 percentage |
| Extended Efficacy Population (EEP) | Patient-level PPV of rhPSMA-7.3 (18F) PET BIE for N1 and M1 Lesions Compared to Histopathology or Confirmatory Imaging (M1 Lesions Only) (Objective 3) | Central Reader 1 | 62.5 percentage |
| Extended Efficacy Population (EEP) | Patient-level PPV of rhPSMA-7.3 (18F) PET BIE for N1 and M1 Lesions Compared to Histopathology or Confirmatory Imaging (M1 Lesions Only) (Objective 3) | Central Reader 3 | 57.1 percentage |
Secondary
Percentage of Patients With Negative Conventional Imaging for M1 Disease in Whom rhPSMA-7.3 (18F) PET Detected at Least One Verified M1 Metastasis, as Determined by Central BIE (Objective 2)
Patients counted in this variable were a subset of those in Point 1 above, where both the numerator and denominator were only counting patients with negative conventional imaging (according to investigator assessment) for M1 disease.
Time frame: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Efficacy Analysis Population | Percentage of Patients With Negative Conventional Imaging for M1 Disease in Whom rhPSMA-7.3 (18F) PET Detected at Least One Verified M1 Metastasis, as Determined by Central BIE (Objective 2) | Central Reader 1 | 8.8 percentage |
| Efficacy Analysis Population | Percentage of Patients With Negative Conventional Imaging for M1 Disease in Whom rhPSMA-7.3 (18F) PET Detected at Least One Verified M1 Metastasis, as Determined by Central BIE (Objective 2) | Central Reader 2 | 13.0 percentage |
| Efficacy Analysis Population | Percentage of Patients With Negative Conventional Imaging for M1 Disease in Whom rhPSMA-7.3 (18F) PET Detected at Least One Verified M1 Metastasis, as Determined by Central BIE (Objective 2) | Central Reader 3 | 8.5 percentage |
Secondary
PPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FP Patient is Defined as Having at Least One FP Region (Right or Left Pelvis), Regardless of Any Coexisting TP Findings (Objective 4)
This analysis included patients in the EAP where rhPSMA-7.3 (18F) imaging detected PLN metastasis. Regions where rhPSMA7.3 (18F) imaging detected no LN metastasis were not included (by definition of PPV), hence only TP and FP regions were considered. TPs were all patients with a surgical pathology confirmed positive region and without a FP region. FP patients were those patients with any rhPSMA7.3 (18F) PETpositive region with negative or no surgical pathology.
Time frame: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Efficacy Analysis Population | PPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FP Patient is Defined as Having at Least One FP Region (Right or Left Pelvis), Regardless of Any Coexisting TP Findings (Objective 4) | Central Reader 2 | 54.5 percentage |
| Efficacy Analysis Population | PPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FP Patient is Defined as Having at Least One FP Region (Right or Left Pelvis), Regardless of Any Coexisting TP Findings (Objective 4) | Central Reader 1 | 48.6 percentage |
| Efficacy Analysis Population | PPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FP Patient is Defined as Having at Least One FP Region (Right or Left Pelvis), Regardless of Any Coexisting TP Findings (Objective 4) | Central Reader 3 | 65.2 percentage |
Secondary
The Percentage of Patients Being Upstaged to N1 or M1 Disease. (Objective 6a)
TP \[confirmed by SoT\] central BIE PET finding and negative conventional imaging finding from the local reading
Time frame: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Efficacy Analysis Population | The Percentage of Patients Being Upstaged to N1 or M1 Disease. (Objective 6a) | Central Reader 1 | 5.1 percentage |
| Efficacy Analysis Population | The Percentage of Patients Being Upstaged to N1 or M1 Disease. (Objective 6a) | Central Reader 2 | 4.3 percentage |
| Efficacy Analysis Population | The Percentage of Patients Being Upstaged to N1 or M1 Disease. (Objective 6a) | Central Reader 3 | 3.7 percentage |
| Extended Efficacy Population (EEP) | The Percentage of Patients Being Upstaged to N1 or M1 Disease. (Objective 6a) | Central Reader 3 | 8.0 percentage |
| Extended Efficacy Population (EEP) | The Percentage of Patients Being Upstaged to N1 or M1 Disease. (Objective 6a) | Central Reader 1 | 8.2 percentage |
| Extended Efficacy Population (EEP) | The Percentage of Patients Being Upstaged to N1 or M1 Disease. (Objective 6a) | Central Reader 2 | 12.2 percentage |
Secondary
The Percentage of Patients in Whom Planned RP Was Converted to EBRT. (Objective 6b)
Time frame: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Efficacy Analysis Population | The Percentage of Patients in Whom Planned RP Was Converted to EBRT. (Objective 6b) | 2.6 percentage |
Secondary
Verified Detection Rate (VDR) for M1 Lesions - Percentage of Patients in Whom rhPSMA-7.3 (18F) Imaging Detected at Least One Verified M1 Metastasis, as Determined by Central BIE and Confirmed by SoT (Biopsy or Imaging) (Objective 1)
This was a key secondary endpoint in this study and included patients in the EEP with rhPSMA-7.3 (18F) imaging.
Time frame: Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET. followed by treatment within 60 days post IMP administration
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Efficacy Analysis Population | Verified Detection Rate (VDR) for M1 Lesions - Percentage of Patients in Whom rhPSMA-7.3 (18F) Imaging Detected at Least One Verified M1 Metastasis, as Determined by Central BIE and Confirmed by SoT (Biopsy or Imaging) (Objective 1) | Central Reader 1 | 9.9 percentage |
| Efficacy Analysis Population | Verified Detection Rate (VDR) for M1 Lesions - Percentage of Patients in Whom rhPSMA-7.3 (18F) Imaging Detected at Least One Verified M1 Metastasis, as Determined by Central BIE and Confirmed by SoT (Biopsy or Imaging) (Objective 1) | Central Reader 2 | 14.2 percentage |
| Efficacy Analysis Population | Verified Detection Rate (VDR) for M1 Lesions - Percentage of Patients in Whom rhPSMA-7.3 (18F) Imaging Detected at Least One Verified M1 Metastasis, as Determined by Central BIE and Confirmed by SoT (Biopsy or Imaging) (Objective 1) | Central Reader 3 | 10.2 percentage |