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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA 7.3 (18F) Positron Emission Tomography (PET) ligand in men with suspected prostate cancer recurrence based on elevated Prostate-specific antigen (PSA) following prior therapy.
The primary objective of this study was to assess the patient-level correct detection rate (CDR) and region-level positive predictive value (PPV) of rhPSMA-7.3 (18F) positron emission tomography (PET) for biochemical recurrence (BCR) of prostate cancer using histopathology or imaging as a standard of truth (SoT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Experimental | Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhPSMA-7.3 (18F) Injection | Drug | Radioligand for PET CT scanning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT | The CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any coexisting FP findings. When determining the region-level PPV, all rhPSMA7.3 (18F) PET-positive regions (maximum of three per patient) were categorized as TP or FP regions using histopathology or imaging. | Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET in Patients Who Had Negative Baseline Conventional Imaging | Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions. |
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Inclusion Criteria:
Patient is male and aged >18 years old.
History of localized adenocarcinoma of the prostate with prior curative intent treatment.
An elevated PSA, clinically suspicious for biochemically recurrent disease:
Potentially eligible for salvage therapy with curative intent.
Exclusion Criteria:
Patients required to have suspected prostate cancer recurrence based on elevated PSA following prior therapy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Tower Urology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38782456 | Derived | Fleming MT, Hermsen R, Purysko AS, Chau A, Davis P, Chapin BF, Schuster DM. True-Positive 18F-Flotufolastat Lesions in Patients with Prostate Cancer Recurrence with Baseline-Negative Conventional Imaging: Results from the Prospective, Phase 3, Multicenter SPOTLIGHT Study. J Nucl Med. 2024 Jul 1;65(7):1080-1086. doi: 10.2967/jnumed.123.267271. |
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Baseline safety evaluations performed at screening (Visit 1) comprised vital signs and recording of any adverse events (AEs) from the time of informed consent. Conventional images collected within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
This study was conducted from 04 May 20 (first patient, screening visit) and 12 Oct 21 (database lock), with last patient, last visit on 28 Apr 21. It was conducted at 28 activated study sites (27 recruited) in 3 countries. Of the 420 patients screened, 391 patients met all the study eligibility criteria
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | All patients who were scheduled to receive the rhPSMA-7.3 (18F) injection having met the inclusion/exclusion criteria or who received the rhPSMA-7.3 (18F) injection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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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 | Oct 23, 2020 | Sep 10, 2025 |
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Positron Emission Tomography (PET) Imaging study
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| Positron emission tomography scan | Diagnostic Test | Imaging scan with radioligand |
|
|
| Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan |
| Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available | Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions. | Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan |
| Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. The last PSA level before the PET scan will be used to stratify the patients | Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan |
| CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other | Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. The analysis was performed for each region and for each of the blinded independent readers | Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan |
| Percentage of Patients in Whom rhPSMA-7.3 (18F) PET Imaging Results Changed the Intended Patient Management (Major and Other Changes) | This analysis used patients in the EAP who had documented patient management plans in the EDC before and after the rhPSMA-7.3 (18F) PET scan | Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan |
| Reader Kappa Statistics of rhPSMA7.3 (18F) Scan Interpretation by the Blinded Independent Readers | The Cohen's kappa statistic will be calculated to assess pairwise agreement between any 2 blinded independent readers | PET Scan on Day 1 |
| Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions.. The last PSA level before the rhPSMA-7.3 (18F) PET scan was used to stratify patients. | Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan |
| Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available | Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions. The data are analysed by whether the patients have had histopathology as reference standard. | Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan |
| Los Angeles |
| California |
| 90048 |
| United States |
| University of California Irvine Medical Center (UCIMC) | Orange | California | 92868 | United States |
| John Wayne Cancer Institute | Santa Monica | California | 90403 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Northside Hospital | Austell | Georgia | 30342 | United States |
| Northshore University HealthSystem | Evanston | Illinois | 60201 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Chesapeake Urology Research Associates | Towson | Maryland | 21204 | United States |
| University of Michigan Ann Arbor | Ann Arbor | Michigan | 48109 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Queens Hospital Center (QHC - Queens Cancer Center | Jamaica | New York | 11432 | United States |
| Mount Sinai Faculty Practice Associates | New York | New York | 10029 | United States |
| Stony Brook University | Stony Brook | New York | 11794 | United States |
| Montefiore Hospital | The Bronx | New York | 10461 | United States |
| Duke University Medical Center | Durham | North Carolina | 27701 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| MidLantic Urology | Philadelphia | Pennsylvania | 19004 | United States |
| MD Anderson Hospital | Houston | Texas | 77054 | United States |
| Urology San Antonio | San Antonio | Texas | 78229 | United States |
| University of Virginia - Health Science Center | Charlottesville | Virginia | 22908 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Turku University Hospital | Turku | FI-20520 | Finland |
| CWZ | Nijmegen | 6532 | Netherlands |
| Maxima MC | Veldhoven | 5504 DB | Netherlands |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All patients who were scheduled to receive the rhPSMA-7.3 (18F) injection having met the inclusion/exclusion criteria or who received the rhPSMA-7.3 (18F) injection.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning Positron emission tomography scan: Imaging scan with radioligand |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Race split into 3 substantive categories and also those for whom it was not reported | Number | participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Total Gleason Score | Gleason score (defined by the International Society of Urological Pathologists) was based on prostate biopsy. Score 6 - The cells look similar to normal prostate cells. The cancer is likely to grow very slowly, if at all Score 7 - Most cells still look similar to normal prostate cells. The cancer is likely to grow slowly Score 8 - Some cells look abnormal. The cancer might grow quickly or at a moderate rate Score 9 or 10 - The cells look very abnormal. The cancer is likely to grow quickly | Number | participants |
| |||||||||||||||||
| Gleason Grade Group (GGG) | GGG (defined by the International Society of Urological Pathologists) was based on prostate biopsy. Group 1: The cells look similar to normal prostate cells. The cancer is likely to grow very slowly, if at all Group 2: Most cells still look similar to normal prostate cells. The cancer is likely to grow slowly Group 3: The cells look less like normal prostate cells. The cancer is likely to grow at a moderate rate Group 4: Some cells look abnormal. The cancer might grow quickly or at a moderate rate Group 5: The cells look very abnormal. The cancer is likely to grow quickly | Number | participants |
| |||||||||||||||||
| TNM (Tumor-Node-Metastasis) Stage T | Pathological TNM stage was used if available, otherwise the clinical TNM was used. T1 means the cancer is too small to be seen on a scan, or felt during an examination of the prostate T1a means that the cancer is in less than 5% of the removed tissue T1c cancers are found by biopsy T2 means the cancer is completely inside the prostate gland T3a means the cancer has broken through the capsule (covering) of the prostate gland T3b means the cancer has spread into the tubes that carry semen (seminal vesicles) T4 means the cancer has spread into other body organs nearby | Number | participants |
| |||||||||||||||||
| TNM Stage N | Pathological TNM stage was used if available, otherwise the clinical TNM was used. N0 means that the nearby lymph nodes don't contain cancer cells N1 means there are cancer cells in lymph nodes near the prostate | Number | participants |
| |||||||||||||||||
| TNM Stage M | Pathological TNM stage was used if available, otherwise the clinical TNM was used. M0 means the cancer hasn't spread to other parts of your body. M1 means the cancer has spread to other parts of the body outside the pelvis. It is split into M1a, M1b and M1c. M1a means there are cancer cells in lymph nodes outside the pelvis M1b means there are cancer cells in the bone M1c means there are cancer cells in other parts of the body such as the lungs | Number | participants |
| |||||||||||||||||
| Body Mass Index (BMI) | BMI was calculated as weight in kg divided by height in m2. | Not all subjects had height and weight measured (eg only 337 subjects had height at baseline) - the trial was conducted during the Covid pandemic. | Mean | Standard Deviation | Kg/m2 |
| |||||||||||||||
| Time since initial cancer diagnosis | Date of cancer diagnosis was not available for 2 participants. | Mean | Standard Deviation | months |
| ||||||||||||||||
| Time since diagnosis of biochemical recurrence | Date of diagnosis of biochemical recurrence not available for all participants | Mean | Standard Deviation | months |
| ||||||||||||||||
| Time since start of adjuvant treatment | Not all participants had adjuvant treatment and start date not always available for all participants who had adjuvant treatment. | Mean | Standard Deviation | months |
| ||||||||||||||||
| Time since end of adjuvant treatment | Not all participants had adjuvant treatment and end date not always available for all participants who had adjuvant treatment. | Mean | Standard Deviation | months |
| ||||||||||||||||
| Duration of adjuvant treatment | Not all participants had adjuvant treatment and start and end dates not always available for all participants who had adjuvant treatment in order to calculate duration. | Mean | Standard Deviation | months |
|
| 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 | Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT | The CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any coexisting FP findings. When determining the region-level PPV, all rhPSMA7.3 (18F) PET-positive regions (maximum of three per patient) were categorized as TP or FP regions using histopathology or imaging. | Patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm. | Posted | Number | 95% Confidence Interval | percentage | Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET in Patients Who Had Negative Baseline Conventional Imaging | Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions. | Patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm. | Posted | Number | 95% Confidence Interval | percentage | Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available | Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions. | Efficacy Analysis Population (EAP): all patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm. | Posted | Number | 95% Confidence Interval | percentage | Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. The last PSA level before the PET scan will be used to stratify the patients | Efficacy Analysis Population (EAP): all patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm, and with baseline PSA available | Posted | Number | 95% Confidence Interval | percentage | Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan |
| ||||||||||||||||||||||||||||||||||||
| Secondary | CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other | Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. The analysis was performed for each region and for each of the blinded independent readers | Efficacy Analysis Population (EAP): all patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm. | Posted | Number | 95% Confidence Interval | percentage | Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients in Whom rhPSMA-7.3 (18F) PET Imaging Results Changed the Intended Patient Management (Major and Other Changes) | This analysis used patients in the EAP who had documented patient management plans in the EDC before and after the rhPSMA-7.3 (18F) PET scan | Patients in the EAP who had documented patient management plans in the EDC before and after the rhPSMA-7.3 (18F) PET scan. | Posted | Number | percentage | Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Reader Kappa Statistics of rhPSMA7.3 (18F) Scan Interpretation by the Blinded Independent Readers | The Cohen's kappa statistic will be calculated to assess pairwise agreement between any 2 blinded independent readers | Evaluable PET Scan Population (EPSP): All patients who received the rhPSMA-7.3 (18F) injection with a PET scan. | Posted | Number | 95% Confidence Interval | percentage | PET Scan on Day 1 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level | Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions.. The last PSA level before the rhPSMA-7.3 (18F) PET scan was used to stratify patients. | Efficacy Analysis Population (EAP): all patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm. | Posted | Number | 95% Confidence Interval | percentage | Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available | Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions. The data are analysed by whether the patients have had histopathology as reference standard. | Efficacy Analysis Population (EAP): all patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and for whom sufficient data are available to permit a clear classification following the SoT algorithm. | Posted | Number | 95% Confidence Interval | percentage | Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan |
|
|
AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration.
AEs (treatment emergent) were coded with MedDRA and data listed by patient: study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were listed by patient
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm | Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning Positron emission tomography scan: Imaging scan with radioligand | 2 | 391 | 2 | 391 | 28 | 391 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sudden death | General disorders | MedDRA 23 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA 23 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 23 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 23 | Systematic Assessment |
| |
| Injection site discomfort | General disorders | MedDRA 23 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 23 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 23 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 23 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 23 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 23 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 23 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 23 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 23 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of R&D | Blue Earth Diagnostics | +44 (0) 1865 784 186 | matthew.miller@blueearthdx.com |
| Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 7, 2021 | Feb 6, 2025 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D007267 | Injections |
| D049268 | Positron-Emission Tomography |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
Not provided
Not provided
| >=65 years |
|
|
| Unknown or Not Reported |
|
| White |
|
|
| Other |
|
|
| Not Reported |
|
|
|
| Finland |
|
|
| =7 |
|
|
| =8 |
|
|
| =9 |
|
|
| =10 |
|
|
| Missing |
|
|
| =2 |
|
|
| =3 |
|
|
| =4 |
|
|
| =5 |
|
|
| Missing |
|
|
| T1c |
|
|
| T2 |
|
|
| T2a |
|
|
| T2b |
|
|
| T2c |
|
|
| T3 |
|
|
| T3a |
|
|
| T3b |
|
|
| T4 |
|
|
| TX |
|
|
| Missing |
|
|
| N1 |
|
|
| NX |
|
|
| Missing |
|
|
| M1 |
|
|
| M1b |
|
|
| MX |
|
|
| Missing |
|
|
|
| Region-level PPV - Central Reader 1 |
|
| Region-level PPV - Central Reader 2 |
|
| Region-level PPV - Central Reader 3 |
|
|
| Participants |
|
|
2.0 ≤ PSA < 5.0
| OG004 | 5.0≤PSA<10.0 | 5.0 ≤ PSA < 10.0 |
| OG005 | PSA≥10.0 | PSA ≥ 10.0 |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| OG004 |
| 5.0≤PSA<10.0 |
5.0 ≤ PSA < 10.0 |
| OG005 | PSA≥10.0 | PSA ≥ 10.0 |
|
|
|
|