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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 Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA) 7.3 (18F) Positron Emission Tomography (PET) ligand in men with newly diagnosed prostate cancer.
Main objective is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central blinded image evaluation [BIE]) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during radical prostatectomy (RP) and pelvic lymph node dissection (PLND). At least one positive pelvic LN on PET (N1) and one positive lymph node (LN) as determined by histopathology (pN1) on the same side of the pelvis (left or right) will be deemed a True Positive (TP) at the patient level.
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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 |
|---|---|---|
| Specificity | The primary objective of the study is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND. | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration |
| Sensitivity | The primary objective of the study is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND. | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration |
| Measure | Description | Time Frame |
|---|---|---|
| Verified Detection Rate (VDR) for M1 Lesions - Percentage of Patients in Whom rhPSMA-7.3 (18F) Imaging Detected at Least One Verified M1 Metastasis, as Determined by Central BIE and Confirmed by SoT (Biopsy or Imaging) (Objective 1) | This was a key secondary endpoint in this study and included patients in the EEP with rhPSMA-7.3 (18F) imaging. | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET. followed by treatment within 60 days post IMP administration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients required to have unfavorable intermediate-, high-risk or very high-risk Prostate Cancer
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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 |
|---|---|---|---|
| 37414702 | Derived | Surasi DS, Eiber M, Maurer T, Preston MA, Helfand BT, Josephson D, Tewari AK, Somford DM, Rais-Bahrami S, Koontz BF, Bostrom PJ, Chau A, Davis P, Schuster DM, Chapin BF; LIGHTHOUSE Study Group. Diagnostic Performance and Safety of Positron Emission Tomography with 18F-rhPSMA-7.3 in Patients with Newly Diagnosed Unfavourable Intermediate- to Very-high-risk Prostate Cancer: Results from a Phase 3, Prospective, Multicentre Study (LIGHTHOUSE). Eur Urol. 2023 Oct;84(4):361-370. doi: 10.1016/j.eururo.2023.06.018. Epub 2023 Jul 5. |
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Baseline safety evaluations performed at screening (Visit 1) comprised vital signs, focused physical examination and recording of any adverse events (AEs) from the time of informed consent.
This study was from 02 Mar 20 (first patient, screening visit) and 18 Feb 22 (database lock), with the last patient, last visit on 21 Jun 21. It was conducted at 34 activated study sites (31 recruited) in 4 countries. Of the 372 patients screened, 356 patients met all the study eligibility criteria. 16 patients were screen failures so not included
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Patients | Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning Positron Emission Tomography scan: imaging test with radioligand |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 1, 2020 | Jul 19, 2024 |
Not provided
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Positron Emission Tomography (PET) Imaging study
Not provided
Not provided
Not provided
Not provided
| Positron Emission Tomography scan | Diagnostic Test | imaging test with radioligand |
|
|
| Percentage of Patients With Negative Conventional Imaging for M1 Disease in Whom rhPSMA-7.3 (18F) PET Detected at Least One Verified M1 Metastasis, as Determined by Central BIE (Objective 2) | Patients counted in this variable were a subset of those in Point 1 above, where both the numerator and denominator were only counting patients with negative conventional imaging (according to investigator assessment) for M1 disease. | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration |
| Patient-level PPV of rhPSMA-7.3 (18F) PET BIE for N1 and M1 Lesions Compared to Histopathology or Confirmatory Imaging (M1 Lesions Only) (Objective 3) | This analysis included patients with rhPSMA-7.3 (18F) imaging and either N1 or M1 lesions detected, where PPV=TP/(TP+FP). | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration |
| PPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FP Patient is Defined as Having at Least One FP Region (Right or Left Pelvis), Regardless of Any Coexisting TP Findings (Objective 4) | This analysis included patients in the EAP where rhPSMA-7.3 (18F) imaging detected PLN metastasis. Regions where rhPSMA7.3 (18F) imaging detected no LN metastasis were not included (by definition of PPV), hence only TP and FP regions were considered. TPs were all patients with a surgical pathology confirmed positive region and without a FP region. FP patients were those patients with any rhPSMA7.3 (18F) PETpositive region with negative or no surgical pathology. | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration |
| NPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FN Patient is Defined as Having at Least One FN Region (Right or Left Pelvis), Regardless of Any Coexisting TN Findings (Objective 5) | This analysis included patients in the EAP with rhPSMA-7.3 (18F) imaging where no LN metastases were detected and LN surgical pathology was available; where NPV=TN/(TN+FN). | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration |
| The Percentage of Patients Being Upstaged to N1 or M1 Disease. (Objective 6a) | TP [confirmed by SoT] central BIE PET finding and negative conventional imaging finding from the local reading | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration |
| The Percentage of Patients in Whom Planned RP Was Converted to EBRT. (Objective 6b) | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration |
| Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7) | Pairwise agreement between any 2 of the 3 readers (Kappa statistic could not be calculated for 2 of the pairwise agreements), and within readers between the initial read and re-read (Kappa statistics could not be calculated for 2 of the within-reader agreements) | PET/CT scans on Day 1 |
| 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 |
| Richard L Roudebush VA Medical Center | Indianapolis | Indiana | 46278 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Chesapeake Urology Research Associates | Towson | Maryland | 21204 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | 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 |
| The Urologic Institute of Northeastern New York - Community | Albany | New York | 12208 | 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 |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | 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 PC | Norfolk | Virginia | 23502 | United States |
| Turku University Hospital | Turku | FI-20520 | Finland |
| Klinik und Poliklinik fur Urologie | Hamburg | 20246 | Germany |
| TU München | Munich | 81675 | Germany |
| CWZ | Nijmegen | 6532 | Netherlands |
| Maxima MC | Veldhoven | 5504 DB | Netherlands |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The FAS comprised 356 patients who were scheduled to receive the rhPSMA-7.3 (18F) injection and met the inclusion/exclusion criteria
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 test with radioligand |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Age, Customized | Age in years split into 2 groups | Number | participants |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Ethnicity split into 2 substantive groups and those for whom it was not reported | 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 |
| |||||||||||||||||
| TNM (Tumor-Node-Metastasis) Stage T | Tumour (T) describes the size or area of the cancer 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, for example after a raised PSA level 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 |
| |||||||||||||||||
| 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 Stage M | Metastasis (M) describes whether the cancer has spread to a different part of the body. 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 |
| |||||||||||||||||
| Prostate-specific antigen (PSA) Characterization (ng/mL) | Number | participants |
| ||||||||||||||||||
| Baseline Risk Category | Baseline Risk Category. High-risk or Very-high risk defined as meeting any one of these criteria: T-stage T3 (including T3a and T3b) or T4, GGG 4 or 5, Primary Gleason pattern 5, or PSA >20 ng/mL. | Number | participants |
| |||||||||||||||||
| TNM Stage N | Node (N) describes whether the cancer has spread to the lymph nodes. 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 |
| |||||||||||||||||
| Body Mass Index | Body mass index on Day 1 (Kg/m2) | Number analyzed differs from overall due to missing data. | Mean | Standard Deviation | Kg/m2 |
| |||||||||||||||
| Time since initial cancer diagnosis | Time since initial cancer diagnosis relative to the date of informed consent. | Mean | Standard Deviation | months |
| ||||||||||||||||
| Time since last PSA Measurement | Number analyzed differs from overall due to missing data. | Mean | Standard Deviation | months |
| ||||||||||||||||
| Last PSA Measurement (ng/mL) | Mean | Standard Deviation | ng/mL |
|
| 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 | Specificity | The primary objective of the study is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND. | Posted | Number | 95% Confidence Interval | percentage | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Sensitivity | The primary objective of the study is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND. | Posted | Number | 95% Confidence Interval | percentage | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Verified Detection Rate (VDR) for M1 Lesions - Percentage of Patients in Whom rhPSMA-7.3 (18F) Imaging Detected at Least One Verified M1 Metastasis, as Determined by Central BIE and Confirmed by SoT (Biopsy or Imaging) (Objective 1) | This was a key secondary endpoint in this study and included patients in the EEP with rhPSMA-7.3 (18F) imaging. | Posted | Number | 95% Confidence Interval | percentage | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET. followed by treatment within 60 days post IMP administration |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Negative Conventional Imaging for M1 Disease in Whom rhPSMA-7.3 (18F) PET Detected at Least One Verified M1 Metastasis, as Determined by Central BIE (Objective 2) | Patients counted in this variable were a subset of those in Point 1 above, where both the numerator and denominator were only counting patients with negative conventional imaging (according to investigator assessment) for M1 disease. | Posted | Number | 95% Confidence Interval | percentage | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Patient-level PPV of rhPSMA-7.3 (18F) PET BIE for N1 and M1 Lesions Compared to Histopathology or Confirmatory Imaging (M1 Lesions Only) (Objective 3) | This analysis included patients with rhPSMA-7.3 (18F) imaging and either N1 or M1 lesions detected, where PPV=TP/(TP+FP). | Posted | Number | 95% Confidence Interval | percentage | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | PPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FP Patient is Defined as Having at Least One FP Region (Right or Left Pelvis), Regardless of Any Coexisting TP Findings (Objective 4) | This analysis included patients in the EAP where rhPSMA-7.3 (18F) imaging detected PLN metastasis. Regions where rhPSMA7.3 (18F) imaging detected no LN metastasis were not included (by definition of PPV), hence only TP and FP regions were considered. TPs were all patients with a surgical pathology confirmed positive region and without a FP region. FP patients were those patients with any rhPSMA7.3 (18F) PETpositive region with negative or no surgical pathology. | Posted | Number | 95% Confidence Interval | percentage | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | NPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FN Patient is Defined as Having at Least One FN Region (Right or Left Pelvis), Regardless of Any Coexisting TN Findings (Objective 5) | This analysis included patients in the EAP with rhPSMA-7.3 (18F) imaging where no LN metastases were detected and LN surgical pathology was available; where NPV=TN/(TN+FN). | Posted | Number | 95% Confidence Interval | percentage | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Patients Being Upstaged to N1 or M1 Disease. (Objective 6a) | TP [confirmed by SoT] central BIE PET finding and negative conventional imaging finding from the local reading | Posted | Number | percentage | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Patients in Whom Planned RP Was Converted to EBRT. (Objective 6b) | Posted | Number | percentage | Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7) | Pairwise agreement between any 2 of the 3 readers (Kappa statistic could not be calculated for 2 of the pairwise agreements), and within readers between the initial read and re-read (Kappa statistics could not be calculated for 2 of the within-reader agreements) | All patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan | Posted | Number | percentage | PET/CT scans on Day 1 |
|
|
All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration.
AEs were coded using MedDRA and data listed by patient, including 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 also 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 | Full Safety Population (FSP) | All patients who received the rhPSMA-7.3 (18F) injection. The FSP was used for all safety summaries. | 0 | 356 | 0 | 356 | 28 | 356 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tracheal deviation | Injury, poisoning and procedural complications | MedDRA 23 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 23 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 23 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 23 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 23 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 23 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 23 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 23 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 23 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 23 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 23 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23 | Systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA 23 | Systematic Assessment |
| |
| Haematuria traumatic | Renal and urinary disorders | MedDRA 23 | Systematic Assessment |
| |
| Lower urinary tract symptoms | Renal and urinary disorders | MedDRA 23 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 23 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 23 | Systematic Assessment |
| |
| Spinal Pain | Musculoskeletal and connective tissue disorders | MedDRA 23 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23 | Systematic Assessment |
| |
| Hyperkalaemia | 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_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 1, 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 |
|
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
|
| Other |
|
|
| Not Reported |
|
|
|
| Finland |
|
|
| Germany |
|
|
| =8 |
|
|
| =9 |
|
|
| =10 |
|
|
| ≤ 6 |
|
|
| T1a |
|
|
| T1c |
|
|
| T2 |
|
|
| T2a |
|
|
| T2b |
|
|
| T2c |
|
|
| T3 |
|
|
| T3a |
|
|
| T3b |
|
|
| T3c |
|
|
| T4 |
|
|
| TX |
|
|
| Missing |
|
|
| =2 |
|
|
| =3 |
|
|
| =4 |
|
|
| =5 |
|
|
| M1 |
|
|
| M1a |
|
|
| M1b |
|
|
| MX |
|
|
| Missing |
|
|
|
|
| >5.0 to 10.0 |
|
|
| >10.0 |
|
|
| Immediate-Risk |
|
|
| N1 |
|
|
| NX |
|
|
| Missing |
|
|
| Title | Measurements |
|---|---|
|
|
|
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|