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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003959-16 | EudraCT Number |
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The current study aimed at evaluating the diagnostic performance of [18F]CTT1057 as a PET imaging agent for detection and localization of Prostate specific membrane antigen (PSMA) positivity in patients diagnosed of biochemical recurrence of prostate cancer (PCa), using a composite truth standard.
Approximately 190 participants were to be enrolled to ensure at least 152 participants were evaluable (i.e. have both an evaluable [18F]CTT1057 Positron emission tomography/Computed Tomography (PET/CT) scan imaging and at least one evaluable Composite Truth Standard (CTS) assessment and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CTs and CTS procedures, which were required for the calculation of the co-primary endpoints.
This was a prospective, open-label, multi center, single-arm Phase III study to evaluate the diagnostic performance of [18F]CTT1057 as a PET imaging agent for detection and localization of PSMA positive tumors in PCa patients diagnosed with biochemical recurrence (BCR) after initial definitive therapy with either radical prostatectomy (RP) or curative intent radiation therapy (RT), using a CTS as reference.
The CTS to be used as reference were hierarchical in nature, with 3 levels of Standard of Truth (SoT) procedures, that were applied as follows:
CTS Level 1: Histopathology if available for the lesion (from prospective biopsy or salvage surgery performed within 8 weeks after the [18F]CTT1057 PET/CT scan); OR in case that histopathology was not available for a lesion, inconclusive or negative (for biopsy only).
CTS Level 2: Imaging diagnostic procedures performed on each patient as clinically indicated per SoC, which included at least a high resolution CT scan with contrast and a [68Ga]Ga-PSMA-11 PET/CT) performed within 8 weeks (either before or after) the [18F]CTT1057 PET/CT scan. Three-month follow-up imaging (from baseline) were also be used as part of the CTS level 2 in cases where it is clinically required for the diagnosis of particular lesion(s); OR if neither of the two above were feasible or deemed appropriate or they were inconclusive.
CTS Level 3: 50% or greater decline in PSA following radiation therapy (as long as no concomitant androgen deprivation therapy (ADT) was given) as per Prostate Cancer Working Group 3 (PCWG3) criteria.
All participants underwent 2 PET/CT scans: one with the investigational agent [18F]CTT1057 and another with [68Ga]Ga-PSMA-11 (as a component of the CTS Level 2 and for a secondary endpoint of assessment of concordance between the 2 PET/CT scans for detection of lesions). The 2 PET imaging procedures were performed at least 14 days apart, and the PET/CT scan sequence for each participant was assigned at random in a 1:1 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET/CT imaging with [18F]CTT1057 followed by [68Ga]Ga-PSMA-11 or vice versa | Experimental | All eligible participants were assigned to one of the following two PET/CT scan sequences at random in a 1:1 ratio:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]CTT1057 | Drug | Single intravenous dose of approximately 370 Mega-Becquerel (MBq) and subsequent PET/CT scan |
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| Measure | Description | Time Frame |
|---|---|---|
| Region-level Correct Localization Rate (CLR) of Vidoflufolastat (18F) | Region-level correct localization rate (CLR) is defined as the percentage of regions containing at least one True Positive (TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings within the same region, out of all regions containing at least one PET-positive finding. | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
| Patient-level Positive Predictive Value (PPV) (With Anatomical Localization) of Vidoflufolastat (18F) | Patient-level positive predictive value (PPV) is defined as the percentage of participants who have at least one True Positive (TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings, out of all participants who are PET/CT scan positive. | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-level Sensitivity of Vidoflufolastat (18F) | Patient-level sensitivity is defined as the percentage of participants who test positive on vidoflufolastat (18F) and Composite Truth Standard (CTS) (True Positive (TP)) among those that are CTS positive (True Positive (TP) or False Negative (FN)). | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
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Inclusion Criteria
by AUA criteria (Cookson et al 2007) for patients who have undergone RP: Initial serum PSA of ≥0.2 ng/ml measured at least 6 weeks after RP with a second confirmatory persistent PSA level of >0.2 ng/ml, or by ASTRO-Phoenix criteria (Roach et al 2006) for patients who have undergone curative-intent radiation therapy (RT): Rise of serum PSA measurement of 2 or more ng/mL above the nadir PSA observed post RT.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Explorer Molecular Imaging center | Sacramento | California | 95816 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40473464 | Derived | Fanti S, Robles Barba JJ, Behr S, Maurer T, Paredes P, Walz J, Duch J, Perdigo MS, Mainta IC, Bonnefoy PB, Coulanges M, Tang J, Seigne C, Wilke C, Catafau AM, Iagaru A, Aggarwal R. Imaging Efficacy of [18F]CTT1057 PET/CT in Patients with Biochemically Recurrent Prostate Cancer: Results from GuidePath-A Phase 3, Prospective Multicenter Study. J Nucl Med. 2025 Aug 1;66(8):1210-1216. doi: 10.2967/jnumed.124.269266. |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Prior to participation in the study, patients had to have biopsy proven prostate adenocarcinoma and diagnosis of biochemical recurrence following initial definitive therapy with either radical prostatectomy or curative intent radiation therapy.
190 participants were randomized using a 1:1 ratio to receive either Sequence 1 (vidoflufolastat (18F) followed by gallium (68Ga) gozetotide; N= 96) or Sequence 2 (gallium (68Ga) gozetotide followed by vidoflufolastat (18F); N=94). Out of the 190 randomized participants, 169 completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | PET/CT Imaging With Vidoflufolastat (18F) Followed by Gallium (68Ga) Gozetotide: Sequence 1 | All eligible participants were assigned to this PET/CT scan sequence at random in a 1:1 ratio: - Sequence 1: vidoflufolastat (18F) on Day 1 (investigational imaging agent of interest) followed by gallium (68Ga) gozetotide at least 14 days apart (as part of CTS if required, and for secondary endpoint) |
| FG001 | PET/CT Imaging With Gallium (68Ga) Gozetotide Followed by Vidoflufolastat (18F): Sequence 2 | All eligible participants were assigned to the following PET/CT scan sequence at random in a 1:1 ratio: - Sequence 2: gallium (68Ga) gozetotide (as part of CTS if required, and for secondary endpoint) on Day 1 followed by vidoflufolastat (18F) (investigational imaging agent of interest) at least 14 days apart |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The Full Analysis Set includes all randomized participants. Per protocol, two PET/CT scans were performed at least 2 weeks apart to ensure a clean safety profile assessment for each PET radiopharmaceutical. Participants were randomly assigned (1:1 ratio) to one of two scan sequences to counter-balance any potential change in lesions between the 2 scans:
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| ID | Title | Description |
|---|---|---|
| BG000 | PET/CT Imaging With Vidoflufolastat (18F) Followed by Gallium (68Ga) Gozetotide or Vice Versa | All eligible participants were assigned to one of the following two PET/CT scan sequences at random in a 1:1 ratio:- Sequence 1: vidoflufolastat (18F) on Day 1 (investigational imaging agent of interest) followed by gallium (68Ga) gozetotide at least 14 days apart (as part of CTS if required, and for secondary endpoint)- Sequence 2: gallium (68Ga) gozetotide (as part of CTS if required, and for secondary endpoint) on Day 1 followed by vidoflufolastat (18F) (investigational imaging agent of interest) at least 14 days apart |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Region-level Correct Localization Rate (CLR) of Vidoflufolastat (18F) | Region-level correct localization rate (CLR) is defined as the percentage of regions containing at least one True Positive (TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings within the same region, out of all regions containing at least one PET-positive finding. | The Efficacy Analysis Set (EFF) included all randomized participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan imaging and at least one evaluable CTS assessment, and did not receive any prohibited systemic antineoplastic therapy before the completion of PET/CTs and CTS procedures. Baseline PSA levels were unavailable for 4 of the 161 participants in the EFF set. | Posted | Number | 95% Confidence Interval | Percentage of regions | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vidoflufolastat (18F) | Participants received vidoflufolastat (18F) on Day 1 or Day 15 (investigational imaging agent of interest) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
The participant cohort was mainly European and White, with only one site initiated in the USA. Furthermore, low participant numbers in some subgroups (i.e. participants with prior curative radiation therapy (RT) and participants with baseline Prostate-specific antigen (PSA) levels >1 ng/mL) precluded interpretation of subgroup analyses. In addition, Composite Truth Standard (CTS) Level 1 (histopathology) was only usable from a very small proportion of patients in this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure Office | Novartis Pharmaceuticals | 862-778-3000 | novartis.email@novartis.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 20, 2021 | Nov 22, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 26, 2023 | Nov 22, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Once eligibility was confirmed, the participants were randomized in IRT to be assigned to one of the following two PET/CT scan sequences at random in a 1:1 ratio:
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| [68Ga]Ga-PSMA-11 | Drug | Single intravenous dose of approximately 150 MBq and subsequent PET/CT scan |
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| Patient-level Specificity of Vidoflufolastat (18F) | Patient-level specificity is defined as the percentage of participants who test negative on vidoflufolastat (18F) and CTS (True Negative (TN)) among those that are CTS negative (True Negative (TN) or False Positive (FP)). | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
| Patient-level Negative Predictive Value (NPV) of Vidoflufolastat (18F) | Patient-level negative predictive value is defined as the percentage of participants who are both vidoflufolastat (18F) and CTS negative (True Negative (TN)) among those who test negative on vidoflufolastat (18F) (True Negative (TN) or False Negative (FN)). | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
| Patient-level Accuracy of Vidoflufolastat (18F) | Patient-level accuracy is defined as the percentage of participants who are CTS and vidoflufolastat (18F) positive (True Positive (TP)) and negative (True Negative (TN)) among those participants that identified on vidoflufolastat (18F) (True Positive (TP), True Negative (TN), False Positive (FP) or False Negative (FN)). | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
| Patient-level Correct Detection Rate (CDR) | Patient-level correct detection rate (CDR) is defined as the percentage of participants who have at least one True Positive (TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings, out of all participants who are scanned. | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
| Patient-level Detection Rate | Patient-level detection rate is defined as the percentage of participants who have at least one PET positive lesion, regardless of True Positive (TP) or False Positive (FP) findings, out of all participants who are scanned. | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
| Region-level Sensitivity of Vidoflufolastat (18F) (Overall) | Region level sensitivity is defined as the percentage of regions that test positive on both vidoflufolastat (18F) and CTS (True Positive (TP)) among those regions that are CTS positive (True Positive (TP) or False Negative (FN)). | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
| Region Level Specificity of Vidoflufolastat (18F) | Region level specificity is defined as the percentage of regions that test negative on both vidoflufolastat (18F) and CTS (True Negative (TN)) among those regions that are CTS negative (False Positive (FP) or True Negative (TN)). | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
| Region Level Negative Predictive Value (NPV) of Vidoflufolastat (18F) | Region level negative predictive value is defined as the percentage of regions that are CTS and vidoflufolastat (18F) negative (True Negative (TN)) among those regions that test negative on vidoflufolastat (18F) (True Negative (TN) or False Negative (FN)). | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
| Region Level Accuracy of Vidoflufolastat (18F) | Region level accuracy is defined as the percentage of regions that are CTS andvidoflufolastat (18F) positive (True Positive (TP)) and negative (True Negative (TN)) among those regions that identified on vidoflufolastat (18F) (True Positive (TP), True Negative (TN), False Positive (FP) and False Negative (FN)). | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
| Patient-level Positive Predictive Value (PPV) of Vidoflufolastat (18F) Related to PSA Levels | Patient-level positive predictive value related to PSA levels is defined as the percentage of participants who have at least one True Positive (TP) lesion (exactly anatomically localized correspondence between vidoflufolastat (18F) PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings, out of all participants who are vidoflufolastat (18F) positive, stratified by PSA levels. This endpoint was analyzed in each of the following subgroups: PSA ≤ 0.5 ng/mL; 0.5 ng/mL<PSA≤1 ng/mL; 1 ng/mL<PSA≤2 ng/mL; 2 ng/mL<PSA≤5 ng/mL; PSA > 5 ng/mL. | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
| Overview of Adverse Events (AEs) and Treatment Emergent Adverse Events (TEAEs) | 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. | From first dosing (Day 1) up to 14 days post dosing |
| Vidoflufolastat (18F) Scan Inter-reader Variability | Inter-reader variability is defined as the agreement among three readers determination of vidoflufolastat (18F) images. | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
| Vidoflufolastat (18F) Scan Intra-reader Variability | Intra-reader variability is defined as the within-reader agreement for two different time points of vidoflufolastat (18F) images. | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
| Concordance Between Vidoflufolastat (18F) and Gallium (68Ga) Gozetotide for Detection of Lesions at Lesion Level Using Central Reads (Overall) | Concordance between vidoflufolastat (18F) and gallium (68Ga) gozetotide for detection of PSMA-positive lesions (location and number) using central reads. | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
| Change in Patient Management Plans Attributed to the Vidoflufolastat (18F) PET/CT Scan | Change in patient management plans attributed to the PET/CT scan is defined as the percentage of participants who underwent a change in intended treatment plan attributed to the vidoflufolastat (18F) PET/CT scan as assessed by pre and post imaging questionnaires. | From randomization up to 14 days after obtaining the results of the vidoflufolastat (18F) PET imaging |
| Marseille |
| 13273 |
| France |
| Novartis Investigative Site | Marseille | 13885 | France |
| Novartis Investigative Site | Nîmes | 30029 | France |
| Novartis Investigative Site | Pierre-Bénite | 69495 | France |
| Novartis Investigative Site | Saint-Priest-en-Jarez | 42270 | France |
| Novartis Investigative Site | Toulouse | 31059 | France |
| Novartis Investigative Site | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Barcelona | 08036 | Spain |
| Novartis Investigative Site | Barcelona | 08041 | Spain |
| Novartis Investigative Site | Valencia | 46026 | Spain |
| Novartis Investigative Site | Geneva | 1211 | Switzerland |
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| Physician Decision |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| ID | Title | Description |
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| OG000 | Central Reader 1 | Central Reading Center 1 |
| OG001 | Central Reader 2 | Central Reading Center 2 |
| OG002 | Central Reader 3 | Central Reading Center 3 |
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| Primary | Patient-level Positive Predictive Value (PPV) (With Anatomical Localization) of Vidoflufolastat (18F) | Patient-level positive predictive value (PPV) is defined as the percentage of participants who have at least one True Positive (TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings, out of all participants who are PET/CT scan positive. | The Efficacy Analysis Set (EFF) included all randomized participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan imaging and at least one evaluable CTS assessment, and did not receive any prohibited systemic antineoplastic therapy before the completion of PET/CTs and CTS procedures. Baseline PSA levels were unavailable for 4 of the 161 participants in the EFF set. | Posted | Number | 95% Confidence Interval | Percentage of participants | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
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| Secondary | Patient-level Sensitivity of Vidoflufolastat (18F) | Patient-level sensitivity is defined as the percentage of participants who test positive on vidoflufolastat (18F) and Composite Truth Standard (CTS) (True Positive (TP)) among those that are CTS positive (True Positive (TP) or False Negative (FN)). | The Efficacy Analysis Set (EFF) included all randomized participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan imaging and at least one evaluable CTS assessment, and did not receive any prohibited systemic antineoplastic therapy before the completion of PET/CTs and CTS procedures. Baseline PSA levels were unavailable for 4 of the 161 participants in the EFF set. | Posted | Number | 95% Confidence Interval | Percentage of participants | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
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| Secondary | Patient-level Specificity of Vidoflufolastat (18F) | Patient-level specificity is defined as the percentage of participants who test negative on vidoflufolastat (18F) and CTS (True Negative (TN)) among those that are CTS negative (True Negative (TN) or 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 at least one evaluable CTS assessment, and did not receive any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery. Baseline PSA levels were unavailable for 4 of the 161 participants in the EFF set. | Posted | Number | 95% Confidence Interval | Percentage of participants | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
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| Secondary | Patient-level Negative Predictive Value (NPV) of Vidoflufolastat (18F) | Patient-level negative predictive value is defined as the percentage of participants who are both vidoflufolastat (18F) and CTS negative (True Negative (TN)) among those who test negative on vidoflufolastat (18F) (True Negative (TN) or False Negative (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 at least one evaluable CTS assessment, and did not receive any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery. Baseline PSA levels were unavailable for 4 of the 161 participants in the EFF set. | Posted | Number | 95% Confidence Interval | Percentage of participants | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
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| Secondary | Patient-level Accuracy of Vidoflufolastat (18F) | Patient-level accuracy is defined as the percentage of participants who are CTS and vidoflufolastat (18F) positive (True Positive (TP)) and negative (True Negative (TN)) among those participants that identified on vidoflufolastat (18F) (True Positive (TP), True Negative (TN), False Positive (FP) or False Negative (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 at least one evaluable CTS assessment, and did not receive any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery. Baseline PSA levels were unavailable for 4 of the 161 participants in the EFF set. | Posted | Number | 95% Confidence Interval | Percentage of participants | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
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| Secondary | Patient-level Correct Detection Rate (CDR) | Patient-level correct detection rate (CDR) is defined as the percentage of participants who have at least one True Positive (TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings, out of all participants who are scanned. | 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 at least one evaluable CTS assessment, and did not receive any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery. Baseline PSA levels were unavailable for 4 of the 161 participants in the EFF set. | Posted | Number | 95% Confidence Interval | Percenage of participants | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
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| Secondary | Patient-level Detection Rate | Patient-level detection rate is defined as the percentage of participants who have at least one PET positive lesion, regardless of True Positive (TP) or False Positive (FP) findings, out of all participants who are scanned. | 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 at least one evaluable CTS assessment, and did not receive any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery. Baseline PSA levels were unavailable for 4 of the 161 participants in the EFF set. | Posted | Number | 95% Confidence Interval | Percentage of participants | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
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| Secondary | Region-level Sensitivity of Vidoflufolastat (18F) (Overall) | Region level sensitivity is defined as the percentage of regions that test positive on both vidoflufolastat (18F) and CTS (True Positive (TP)) among those regions that are CTS positive (True Positive (TP) or False Negative (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 at least one evaluable CTS assessment, and did not receive any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery. Baseline PSA levels were unavailable for 4 of the 161 participants in the EFF set. | Posted | Number | 95% Confidence Interval | Percentage of regions | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
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| Secondary | Region Level Specificity of Vidoflufolastat (18F) | Region level specificity is defined as the percentage of regions that test negative on both vidoflufolastat (18F) and CTS (True Negative (TN)) among those regions that are CTS negative (False Positive (FP) or True Negative (TN)). | 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 at least one evaluable CTS assessment, and did not receive any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery. Baseline PSA levels were unavailable for 4 of the 161 participants in the EFF set. | Posted | Number | 95% Confidence Interval | Percentage of regions | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
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| Secondary | Region Level Negative Predictive Value (NPV) of Vidoflufolastat (18F) | Region level negative predictive value is defined as the percentage of regions that are CTS and vidoflufolastat (18F) negative (True Negative (TN)) among those regions that test negative on vidoflufolastat (18F) (True Negative (TN) or False Negative (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 at least one evaluable CTS assessment, and did not receive any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery. Baseline PSA levels were unavailable for 4 of the 161 participants in the EFF set. | Posted | Number | 95% Confidence Interval | Percentage of regions | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
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| Secondary | Region Level Accuracy of Vidoflufolastat (18F) | Region level accuracy is defined as the percentage of regions that are CTS andvidoflufolastat (18F) positive (True Positive (TP)) and negative (True Negative (TN)) among those regions that identified on vidoflufolastat (18F) (True Positive (TP), True Negative (TN), False Positive (FP) and False Negative (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 at least one evaluable CTS assessment, and did not receive any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery. Baseline PSA levels were unavailable for 4 of the 161 participants in the EFF set. | Posted | Number | 95% Confidence Interval | Percentage of regions | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
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| Secondary | Patient-level Positive Predictive Value (PPV) of Vidoflufolastat (18F) Related to PSA Levels | Patient-level positive predictive value related to PSA levels is defined as the percentage of participants who have at least one True Positive (TP) lesion (exactly anatomically localized correspondence between vidoflufolastat (18F) PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings, out of all participants who are vidoflufolastat (18F) positive, stratified by PSA levels. This endpoint was analyzed in each of the following subgroups: PSA ≤ 0.5 ng/mL; 0.5 ng/mL<PSA≤1 ng/mL; 1 ng/mL<PSA≤2 ng/mL; 2 ng/mL<PSA≤5 ng/mL; PSA > 5 ng/mL. | 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 at least one evaluable CTS assessment, and did not receive any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery. Baseline PSA levels were unavailable for 4 of the 161 participants in the EFF set. | Posted | Number | 95% Confidence Interval | Percentage of Participants | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
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| Secondary | Overview of Adverse Events (AEs) and Treatment Emergent Adverse Events (TEAEs) | 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 (SAF): All participants who received at least one dose of vidoflufolastat (18F) or Gallium (68Ga) gozetotide. The vidoflufolastat (18F) Safety Set (F-SAF) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)). The gallium (68Ga) gozetotide safety Set (Ga-SAF) included all participants who received Gallium (68Ga) gozetotide. | Posted | Count of Participants | Participants | From first dosing (Day 1) up to 14 days post dosing |
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| Secondary | Vidoflufolastat (18F) Scan Inter-reader Variability | Inter-reader variability is defined as the agreement among three readers determination of vidoflufolastat (18F) images. | The vidoflufolastat (18F) Safety Set (F-SAF) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)). | Posted | Number | 95% Confidence Interval | % agreement | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
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| Secondary | Vidoflufolastat (18F) Scan Intra-reader Variability | Intra-reader variability is defined as the within-reader agreement for two different time points of vidoflufolastat (18F) images. | The vidoflufolastat (18F) Safety Set (F-SAF) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)). Scans for a subset of 19 participants from the vidoflufolastat (18F) safety set were read by each reader at 2 different time points | Posted | Number | 95% Confidence Interval | % agreement | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
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| Secondary | Concordance Between Vidoflufolastat (18F) and Gallium (68Ga) Gozetotide for Detection of Lesions at Lesion Level Using Central Reads (Overall) | Concordance between vidoflufolastat (18F) and gallium (68Ga) gozetotide for detection of PSMA-positive lesions (location and number) using central reads. | The vidoflufolastat (18F) Safety Set (F-SAF) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)). | Posted | Number | 95% Confidence Interval | Percentage of lesions | vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment) |
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| Secondary | Change in Patient Management Plans Attributed to the Vidoflufolastat (18F) PET/CT Scan | Change in patient management plans attributed to the PET/CT scan is defined as the percentage of participants who underwent a change in intended treatment plan attributed to the vidoflufolastat (18F) PET/CT scan as assessed by pre and post imaging questionnaires. | The vidoflufolastat (18F) Safety Set (F-SAF) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)). | Posted | Count of Participants | Participants | From randomization up to 14 days after obtaining the results of the vidoflufolastat (18F) PET imaging |
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| 0 |
| 171 |
| 1 |
| 171 |
| 20 |
| 171 |
| EG001 | Gallium (68Ga) Gozetotide | Participants received gallium (68Ga) gozetotide (as part of CTS if required, and for secondary endpoint) on Day 1 or Day 15 | 0 | 178 | 0 | 178 | 16 | 178 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Paraesthesia oral | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (26.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (26.1) | Systematic Assessment |
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| Injection site warmth | General disorders | MedDRA (26.1) | Systematic Assessment |
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| Malaise | General disorders | MedDRA (26.1) | Systematic Assessment |
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| Thirst | General disorders | MedDRA (26.1) | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
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| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
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| Cognitive disorder | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
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| Apathy | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
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| Renal pain | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e., data from all sites) in clinical trial or disclosure of trial results in their entirety.
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Subgroup: 0.5 ng/mL <PSA <= 1 ng/mL (n = 29, 29, 29) |
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| Subgroup: 1 ng/mL <PSA <= 2 ng/mL (n = 11, 11, 11) |
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| Subgroup: 2 ng/mL <PSA <= 5 ng/mL (n=11,11,11) |
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| Subgroup: PSA > 5 ng/mL (n = 6,6,6) |
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| Serious Adverse Events (SAEs) |
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| Treatment-related SAEs |
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| Fatal serious AEs |
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| Treatment-related fatal AEs |
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| AEs leading to treatment discontinuation |
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| Treatment-related AEs leading to treatment discontinuation |
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| AEs leading to dose adjustment / interruption |
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| AEs requiring additional therapy |
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