| Primary | Patient-level Sensitivity of Vidoflufolastat (18F) - % Sensitivity | Sensitivity of vidoflufolastat (18F) Positron Emission Tomography (PET) imaging, considering Prostate Specific Membrane Antigen (PSMA) positive patients as those who show at least one pathological vidoflufolastat (18F) uptake either in the primary tumor and/or metastatic Pelvic Lymph Node (PLN) regions, with anatomically localized correspondence with the Standard of Truth (SoT). | The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and histopathology assessment, and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery. | Posted | | Number | 95% Confidence Interval | % Sensitivity | | vidoflufolastat (18F)7 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan | | | | ID | Title | Description |
|---|
| OG000 | Central Reader 1 | | | OG001 | Central Reader 2 | | | OG002 | Central Reader 3 | |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00086.8(80.74 to 91.56)
- OG00190.0(84.47 to 94.07)
- OG00286.9(80.85 to 91.61)
|
|
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| Primary | Region-level Specificity of Vidoflufolastat (18F) - % Specificity | Specificity of vidoflufolastat (18F) PET imaging, defined as proportion of PLN regions that test negative for lymph nodes on vidoflufolastat (18F) among those that are lymph node negative on the SoT. | The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and histopathology assessment, and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery. | Posted | | Number | 95% Confidence Interval | % Specificity | | vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan | | | | ID | Title | Description |
|---|
| OG000 | Central Reader 1 | | | OG001 | Central Reader 2 | | | OG002 | Central Reader 3 | |
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| Secondary | Patient-level Specificity of Vidoflufolastat (18F) - % Specificity | Specificity of vidoflufolastat (18F) PET imaging, considering PSMA negative patients as those who do not show any pathological vidoflufolastat (18F) uptake either in the primary tumor or PLNs and will be confirmed not having primary tumor or metastatic PLNs with the SoT | The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and histopathology assessment, and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery. | Posted | | Number | 95% Confidence Interval | % Specificity | | vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan | | | | ID | Title | Description |
|---|
| OG000 | Central Reader 1 | | | OG001 | Central Reader 2 | | | OG002 | Central Reader 3 | |
| |
| Secondary | Patient-level Positive Predictive Value of Vidoflufolastat (18F) | Proportion of patients who are both vidoflufolastat (18F) and SoT positive (true positives (TP) among those who test positive on vidoflufolastat (18F) (TP+ false positives (FP)) | The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and histopathology assessment, and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery. | Posted | | Number | 95% Confidence Interval | % Positive Predictive Value | | vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan | | | | ID | Title | Description |
|---|
| OG000 | Central Reader 1 | | | OG001 | Central Reader 2 | | | OG002 | Central Reader 3 | |
| |
| Secondary | Patient-level Negative Predictive Value of Vidoflufolastat (18F) | Proportion of patients who are both vidoflufolastat (18F) and SoT negative (true negatives (TN)) among those who test negative on vidoflufolastat (18F) (TN+ false negatives (FN)) | The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and histopathology assessment, and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery. | Posted | | Number | 95% Confidence Interval | % Negative Predictive Value | | vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan | | | | ID | Title | Description |
|---|
| OG000 | Central Reader 1 | | | OG001 | Central Reader 2 | | | OG002 | Central Reader 3 | |
| |
| Secondary | Patient-level Accuracy of Vidoflufolastat (18F) | Proportion of patients that are SoT and vidoflufolastat (18F) positive (TP) and negative (TN) among all patients in Efficacy Analysis Set (EFF) (TP+TN+FP+FN) | The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and histopathology assessment, and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery. | Posted | | Number | 95% Confidence Interval | % Accuracy | | vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan | | | | ID | Title | Description |
|---|
| OG000 | Central Reader 1 | | | OG001 | Central Reader 2 | | | OG002 | Central Reader 3 | |
| |
| Secondary | Region-level Sensitivity of Vidoflufolastat (18F) - % Sensitivity | Proportion of PLN regions that test positive on both vidoflufolastat (18F) and SoT (TP) among those that are SoT positive (TP+FN) | The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and histopathology assessment, and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery. | Posted | | Number | 95% Confidence Interval | % Sensitivity | | vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan | | | | ID | Title | Description |
|---|
| OG000 | Central Reader 1 | | | OG001 | Central Reader 2 | | | OG002 | Central Reader 3 | |
| |
| Secondary | Region-level Positive Predictive Value of Vidoflufolastat (18F) | Proportion of Pelvic Lymph Node (PLN) regions that are Standard of Truth (SoT) and vidoflufolastat (18F) positive (TP) among those regions that test positive on vidoflufolastat (18F) (TP+False Positive (FP)) | The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and histopathology assessment, and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery. | Posted | | Number | 95% Confidence Interval | % Positive Predictive Value | | vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan | | | | ID | Title | Description |
|---|
| OG000 | Central Reader 1 | | | OG001 | Central Reader 2 | | | OG002 | Central Reader 3 | |
| |
| Secondary | Region-level Negative Predictive Value of Vidoflufolastat (18F) | Proportion of PLN regions that are SoT and vidoflufolastat (18F) negative (TN) among those regions that test negative on vidoflufolastat (18F) (TN+FN) | The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and histopathology assessment, and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery. | Posted | | Number | 95% Confidence Interval | % Negative Predictive Value | | vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan | | | | ID | Title | Description |
|---|
| OG000 | Central Reader 1 | | | OG001 | Central Reader 2 | | | OG002 | Central Reader 3 | |
| |
| Secondary | Region-level Accuracy of Vidoflufolastat (18F) | Proportion of PLN regions that are SoT and vidoflufolastat (18F) positive (TP) and negative (TN) among all PLN regions assessed vidoflufolastat (18F)(TP+TN+FP+FN) | The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and histopathology assessment, and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery. | Posted | | Number | 95% Confidence Interval | % Accuracy | | vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan | | | | ID | Title | Description |
|---|
| OG000 | Central Reader 1 | | | OG001 | Central Reader 2 | | | OG002 | Central Reader 3 | |
| |
| Secondary | Region-level Sensitivity of Vidoflufolastat (18F) Scan With Standard of Truth Excluding Pelvic Lymph Node (PLN) Metastasis < 2 mm | Sensitivity of vidoflufolastat (18F) PET imaging in the PLN region, excluding from the analysis those lymph nodes showing metastasis <2mm (micro-metastasis) | The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and histopathology assessment, and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery. | Posted | | Number | 95% Confidence Interval | % Sensitivity | | vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan | | | | ID | Title | Description |
|---|
| OG000 | Central Reader 1 | | | OG001 | Central Reader 2 | | | OG002 | Central Reader 3 | |
| |
| Secondary | Detection of Distant Metastasis of Vidoflufolastat (18F) Scan - Participants With at Least One Distant Metastatic Lesion (%) | Number of distant metastasis identified at PET/CT scan in all patients, and percentage of patients with at least one distant metastatic lesion (extra-PLN, visceral or skeletal)identified by PET scan in all patients with an evaluable vidoflufolastat (18F) PET/CT scan. | Safety set - all treated patients | Posted | | Count of Participants | | Participants | | vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan | | | | ID | Title | Description |
|---|
| OG000 | Central Reader 1 | | | OG001 | Central Reader 2 | | | OG002 | Central Reader 3 | |
| |
| Secondary | Overview of Adverse Events | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject | Safety set - all treated patients | Posted | | Count of Participants | | Participants | | Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days. | | | | ID | Title | Description |
|---|
| OG000 | PET/CT Imaging With Vidoflufolastat (18F). | Study participants were injected intravenously with approximately 370 MBq (range 266 - 407 MBq) of vidoflufolastat (18F). |
| |
| Secondary | Vidoflufolastat (18F) Scan Inter-reader Variability - % | Scan inter-reader variability is defined the agreement rate among reader determination of vidoflufolastat (18F) images. | Safety set - all treated patients | Posted | | Number | 95% Confidence Interval | % variability | | vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan | | | | ID | Title | Description |
|---|
| OG000 | PET/CT Imaging With Vidoflufolastat (18F). | Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan |
| |
| Secondary | Vidoflufolastat (18F) Scan Inter-reader Variability - Number of Scans Agreed | Scan inter-reader variability is defined the agreement rate among reader determination of vidoflufolastat (18F) images. | Safety set - all treated patients | Posted | | Count of Participants | | Participants | | vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan | | | | ID | Title | Description |
|---|
| OG000 | PET/CT Imaging With Vidoflufolastat (18F). | Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan |
| |
| Secondary | Vidoflufolastat (18F) Scan Intra-reader Variability | Scan intra-reader variability is defined as the within-reader agreement rate of vidoflufolastat (18F) images. | Safety set - all treated patients with a valid measurement. For this outcome measure, scans for a subset of 20 patients were read by each reader at 2 different time points. | Posted | | Number | 95% Confidence Interval | variability (%) | | vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan | | | | ID | Title | Description |
|---|
| OG000 | Central Reader 1 | | | OG001 | Central Reader 2 | | | OG002 | Central Reader 3 | |
| |
| Secondary | Observed Maximum Blood Concentration (Cmax) of Vidoflufolastat (18F) | | The Pharmacokinetic analysis set (PAS) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)) with valid results for the outcome measure. For PK outcome measures, a subset of 10 patients maximum were analyzed. | Posted | | Mean | Standard Deviation | kBq/mL | | Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection) | | | | ID | Title | Description |
|---|
| OG000 | PET/CT Imaging With Vidoflufolastat (18F). | Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan |
| |
| Secondary | Time of Maximum Observed Blood Concentration Occurrence (Tmax) of Vidoflufolastat (18F) | | The Pharmacokinetic analysis set (PAS) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)) with valid results for the outcome measure. For PK outcome measures, a subset of 10 patients maximum were analyzed. | Posted | | Median | Full Range | Hours | | Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection) | | | | ID | Title | Description |
|---|
| OG000 | PET/CT Imaging With Vidoflufolastat (18F). | Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan |
| |
| Secondary | Area Under the Vidoflufolastat (18F) Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) | | The Pharmacokinetic analysis set (PAS) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)) with valid results for the outcome measure. For PK outcome measures, a subset of 10 patients maximum were analyzed. | Posted | | Mean | Standard Deviation | h*kBq/mL | | Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection) | | | | ID | Title | Description |
|---|
| OG000 | PET/CT Imaging With Vidoflufolastat (18F). | Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan |
| |
| Secondary | Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf) of Vidoflufolastat (18F) | | The Pharmacokinetic analysis set (PAS) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)) with valid results for the outcome measure. For PK outcome measures, a subset of 10 patients maximum were analyzed. For this parameter, results for only 1 pt were evaluable. | Posted | | Mean | Standard Deviation | h*kBq/mL | | Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post infusion) | | | | ID | Title | Description |
|---|
| OG000 | PET/CT Imaging With Vidoflufolastat (18F). | Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan |
| |
| Secondary | Half-Life Lambda z of Vidoflufolastat (18F) | | The Pharmacokinetic analysis set (PAS) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)) with valid results for the outcome measure. For PK outcome measures, a subset of 10 patients maximum were analyzed. For this parameter, results for only 1 pt were evaluable. | Posted | | Mean | Standard Deviation | h | | Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection) | | | | ID | Title | Description |
|---|
| OG000 | PET/CT Imaging With Vidoflufolastat (18F). | Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan |
| |
| Secondary | Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) of Vidoflufolastat (18F) | | The Pharmacokinetic analysis set (PAS) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)) with valid results for the outcome measure. For PK outcome measures, a subset of 10 patients maximum were analyzed. For this parameter, results for only 1 pt were evaluable. | Posted | | Mean | Standard Deviation | L | | Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection) | | | | ID | Title | Description |
|---|
| OG000 | PET/CT Imaging With Vidoflufolastat (18F). | Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan |
| |
| Secondary | Urinary Excretion of Radioactivity Expressed as a Percentage of Injected Activity (%IA) of Vidoflufolastat (18F) | | The Pharmacokinetic analysis set (PAS) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)) with valid results for the outcome measure. For PK outcome measures, a subset of 10 patients maximum were analyzed. | Posted | | Mean | Standard Deviation | %IA | | Day 1 (pre-injection/0 hour, 0 hour (injection) - T (image acquisition starting time), T (image acquisition starting time) to 3 hours, 3 hours to 5 hours post imaging) | | | | ID | Title | Description |
|---|
| OG000 | PET/CT Imaging With Vidoflufolastat (18F). | Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan |
| |
| Secondary | Total Systemic Clearance for Intravenous Administration (CL) of Vidoflufolastat (18F) | | The Pharmacokinetic analysis set (PAS) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)) with valid results for the outcome measure. For PK outcome measures, a subset of 10 patients maximum were analyzed. For this parameter, results for only 1 pt were evaluable. | Posted | | Mean | Standard Deviation | L/h | | Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection) | | | | ID | Title | Description |
|---|
| OG000 | PET/CT Imaging With Vidoflufolastat (18F). | Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan |
| |