Clinical Trial Results:
Phase II/III study for evaluation of the diagnostic performance of [18F]CTT1057 PET imaging for the detection of PSMA positive tumors using histopathology as a standard of truth (GuideView)
Summary
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EudraCT number |
2020-003958-67 |
Trial protocol |
FR ES IT |
Global end of trial date |
24 Nov 2023
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Results information
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Results version number |
v1 |
This version publication date |
09 Nov 2024
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First version publication date |
09 Nov 2024
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Other versions |
v2 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CAAA405A12302
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04838626 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Novartis Pharma AG
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Sponsor organisation address |
Novartis Campus, Basel, Switzerland,
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Public contact |
Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
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Scientific contact |
Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
24 Nov 2023
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
24 Nov 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objectives were:
• Evaluate the patient-level sensitivity of vidoflufolastat (18F)
• Evaluate the region-level specificity of vidoflufolastat (18F)
Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com for complete trial results.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
07 Sep 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
France: 45
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Country: Number of subjects enrolled |
Italy: 54
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Country: Number of subjects enrolled |
Spain: 80
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Country: Number of subjects enrolled |
Switzerland: 12
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Country: Number of subjects enrolled |
United States: 4
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Worldwide total number of subjects |
195
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EEA total number of subjects |
179
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
92
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From 65 to 84 years |
103
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85 years and over |
0
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Recruitment
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Recruitment details |
195 patients were enrolled. 184 participants received vidoflufolastat (18F) and 184 underwent PET/CT. 173 patients completed the study and 184 patients completed treatment. | ||||||||||||||||||
Pre-assignment
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Screening details |
A total of 195 participants were enrolled. 184 participants completed the study treatment phase (PET imaging completed) | ||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||
Arms
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Arm title
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PET/CT imaging with vidoflufolastat (18F). | ||||||||||||||||||
Arm description |
Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
vidoflufolastat (18F)
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Investigational medicinal product code |
AAA405
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Other name |
[18F]CTT1057
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan
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Baseline characteristics reporting groups
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Reporting group title |
PET/CT imaging with vidoflufolastat (18F).
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Reporting group description |
Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
PET/CT imaging with vidoflufolastat (18F).
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Reporting group description |
Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan | ||
Subject analysis set title |
Central Reader 1
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Central Reading Center 1
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Subject analysis set title |
Central Reader 2
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Central Reading Center 2
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Subject analysis set title |
Central Reader 3
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Central Reading Center 3
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Subject analysis set title |
Central Reader 1
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Central Reading Center 1
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Subject analysis set title |
Central Reader 2
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Central Reading Center 2
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Subject analysis set title |
Central Reader 3
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Central Reading Center 3
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Subject analysis set title |
Central Reader 1
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Central Reader 1
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Subject analysis set title |
Central Reader 2
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Central Reader 2
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Subject analysis set title |
Central Reader 3
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Central Reader 3
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End point title |
Patient-level sensitivity of vidoflufolastat (18F) - % Sensitivity [1] | ||||||||||||||||
End point description |
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).
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End point type |
Primary
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End point timeframe |
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
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Not applicable for a single treatment arm study. |
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No statistical analyses for this end point |
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End point title |
Region-level specificity of vidoflufolastat (18F) - % Specificity [2] | ||||||||||||||||
End point description |
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.
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End point type |
Primary
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End point timeframe |
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
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Not applicable for a single treatment arm study. |
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No statistical analyses for this end point |
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End point title |
Patient-level specificity of vidoflufolastat (18F) - % Specificity | ||||||||||||||||
End point description |
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
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End point type |
Secondary
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End point timeframe |
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
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No statistical analyses for this end point |
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End point title |
Patient-level positive predictive value of vidoflufolastat (18F) | ||||||||||||||||
End point description |
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))
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End point type |
Secondary
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End point timeframe |
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
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No statistical analyses for this end point |
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End point title |
Patient-level accuracy of vidoflufolastat (18F) | ||||||||||||||||
End point description |
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)
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End point type |
Secondary
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End point timeframe |
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
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No statistical analyses for this end point |
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End point title |
Patient-level negative predictive value of vidoflufolastat (18F) | ||||||||||||||||
End point description |
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))
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End point type |
Secondary
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End point timeframe |
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
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No statistical analyses for this end point |
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End point title |
Region-level Sensitivity of vidoflufolastat (18F) - % Sensitivity | ||||||||||||||||
End point description |
Proportion of PLN regions that test positive on both vidoflufolastat (18F) and SoT (TP) among those that are SoT positive (TP+FN)
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End point type |
Secondary
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End point timeframe |
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
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No statistical analyses for this end point |
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End point title |
Region-level positive predictive value of vidoflufolastat (18F) | ||||||||||||||||
End point description |
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))
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End point type |
Secondary
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End point timeframe |
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
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No statistical analyses for this end point |
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End point title |
Region-level accuracy of vidoflufolastat (18F) | ||||||||||||||||
End point description |
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)
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End point type |
Secondary
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End point timeframe |
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
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No statistical analyses for this end point |
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End point title |
Region-level negative predictive value of vidoflufolastat (18F) | ||||||||||||||||
End point description |
Proportion of PLN regions that are SoT and vidoflufolastat (18F) negative (TN) among those regions that test negative on vidoflufolastat (18F) (TN+FN)
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End point type |
Secondary
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End point timeframe |
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
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No statistical analyses for this end point |
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End point title |
Region-level sensitivity of vidoflufolastat (18F) scan with standard of truth excluding Pelvic Lymph Node (PLN) metastasis < 2 mm | ||||||||||||||||
End point description |
Sensitivity of vidoflufolastat (18F) PET imaging in the PLN region, excluding from the analysis those lymph nodes showing metastasis <2mm (micro-metastasis)
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End point type |
Secondary
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End point timeframe |
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
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No statistical analyses for this end point |
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End point title |
Overview of adverse events | ||||||||||||||||||||||
End point description |
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.
AEs = Adverse Events
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End point type |
Secondary
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End point timeframe |
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.
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No statistical analyses for this end point |
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End point title |
Detection of distant metastasis of vidoflufolastat (18F) scan - Participants with at least one distant metastatic lesion (%) | ||||||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
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
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No statistical analyses for this end point |
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End point title |
vidoflufolastat (18F) scan inter-reader variability - Number of scans agreed | ||||||||||
End point description |
Scan inter-reader variability is defined the agreement rate among reader determination of vidoflufolastat (18F) images.
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End point type |
Secondary
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End point timeframe |
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
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No statistical analyses for this end point |
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End point title |
vidoflufolastat (18F) scan inter-reader variability - % | ||||||||
End point description |
Scan inter-reader variability is defined the agreement rate among reader determination of vidoflufolastat (18F) images.
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End point type |
Secondary
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End point timeframe |
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
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No statistical analyses for this end point |
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End point title |
vidoflufolastat (18F) scan intra-reader variability | ||||||||||||||||
End point description |
Scan intra-reader variability is defined as the within-reader agreement rate of vidoflufolastat (18F) images.
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End point type |
Secondary
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End point timeframe |
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
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No statistical analyses for this end point |
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End point title |
Observed maximum blood concentration (Cmax) of vidoflufolastat (18F) | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
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No statistical analyses for this end point |
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End point title |
Time of maximum observed blood concentration occurrence (Tmax) of vidoflufolastat (18F) | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
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No statistical analyses for this end point |
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End point title |
Area under the vidoflufolastat (18F) concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
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No statistical analyses for this end point |
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End point title |
Volume of distribution during the terminal phase following intravenous elimination (Vz) of vidoflufolastat (18F) | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
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No statistical analyses for this end point |
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End point title |
Urinary excretion of radioactivity expressed as a percentage of injected activity (%IA) of vidoflufolastat (18F) | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
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)
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No statistical analyses for this end point |
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End point title |
Half-Life Lambda z of vidoflufolastat (18F) | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
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No statistical analyses for this end point |
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End point title |
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) of vidoflufolastat (18F) | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post infusion)
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No statistical analyses for this end point |
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End point title |
Total systemic clearance for intravenous administration (CL) of vidoflufolastat (18F) | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
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.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26.1
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Reporting groups
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Reporting group title |
All Subjects
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Reporting group description |
All Subjects | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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20 Dec 2021 |
The main purpose of the amendment was to update the inclusion criterion on the definition of high-risk prostate cancer per D'Amico classification to also include participants with clinical stage T2c or higher at initial diagnosis (instead of T2c only) as they were also considered high-risk per D’Amico classification. Other clarifications and corrections of discrepancies or errors were implemented across the protocol. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com for complete trial results. |