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| ID | Type | Description | Link |
|---|---|---|---|
| 212082PCR2005 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to show that abiraterone acetate plus prednisone added to the current standard of care, gonadotropin-releasing hormone (GnRH) decreases prostate specific antigen (PSA) and prolongs the time until it is evident that the cancer has grown. Additionally, safety information about abiraterone acetate in combination with prednisone will be collected. This will include looking at what side effects occur, how often they occur, and for how long they last.
This is a Phase 2, prospective, multicenter, open-label, single-arm study of abiraterone acetate plus prednisone in men with non-metastatic, castration-resistant prostate cancer (CRPC) who have a rising PSA despite castrate levels of testosterone. The study consists of Screening Phase (up to 4 weeks), Core Study Treatment Phase (comprised of six 28-day cycles), a Pre-metastatic Disease Follow-up Phase, an Optional Drug Holiday Phase; and a 30-day Safety Follow-up Visit. Each treatment cycle will last 28 days. Participating participants will receive study agents (Abiraterone acetate 1000 mg/day plus prednisone 5 mg/day, orally) continually during the study. If the partcipants elects to participate in the Optional Drug Holiday Phase, participants will discontinue abiraterone acetate plus prednisone and ADT. Participants will have the option to return to study medication during the first year of the Optional Drug Holiday Phase if there is evidence of rising PSA but no metastasis based on study imaging. If participants do no elect to participate, they will continue with the core study treatment as per protocol. The study will end when all participated participants have disease progression or end of the 2-year period (if participants participated in the Optional Drug Holiday Phase). Participants will be required to return to the study site 30 days after receiving the last dose of abiraterone acetate for safety follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | abiraterone acetate in combination with prednisone Abiraterone acetate will be taken as 4 x 250 mg tablets by mouth (PO) once daily. Prednisone will be taken as 2 x 2.5 mg tablets PO once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abiraterone acetate in combination with prednisone | Drug | Abiraterone acetate will be taken as 4 x 250 mg tablets by mouth (PO) once daily. Prednisone will be taken as 2 x 2.5 mg tablets PO once daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study | Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed. | End of core study visit (Approximately at Month 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Radiographic Evidence of Disease Progression (TTRP) | Time to radiographic evidence of disease progression is defined as the time interval from the date of enrollment (Day 1) to the date of disease progression. A participant was considered as progressed by bone scan if: 1) The appearance of greater than or equal to (>=) 2 new lesions, and, following the first assessment, a confirmatory scan performed 6 or more weeks later that shows a minimum of 2 or more additional new lesions, 2) If >=2 new lesions are seen on scans following the first assessment, the confirmation is still required after 6 weeks; however, 2 addition lesions are not required to confirm progression, and 3) The date of progression is the date of the first scan that shows the changes. |
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Major Inclusion Criteria:
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Services, LLC. Clinical Trial | Janssen Biotech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Homewood | Alabama | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Abiraterone Acetate Plus Prednisone | Participants were given abiraterone acetate 1000 milligrams (mg) (4*250 mg) tablets plus prednisone 5 mg (2*2.5 mg) tablets orally once daily in core study treatment phase (comprised of 6, 28-day cycles). After the core study treatment phase, participants who entered the pre-metastatic disease follow-up phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial. As per amendment 6, participants who opted for the drug holiday phase stopped abiraterone acetate plus prednisone, and androgen-deprivation therapy (ADT), with the option to restart treatment within the first year if prostate-specific antigen (PSA) levels increased without metastasis. Those who did not opt for the drug holiday phase continued treatment. The study ended when all participants had disease progression or completed the 2-year period (for drug holiday participants) (up to 140 months; 153 Cycles). Post-metastatic disease follow-up phase was also discontinued, though participants already enrolled at the time of protocol amendment 6 remained on study. A safety follow-up visit was required 30 days after the last dose of abiraterone acetate. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 1, 2018 | Dec 1, 2025 |
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| Maximum up to Month 30.5 |
| Time to Prostate-Specific Antigen (PSA) Progression | Time to PSA progression is defined as the time interval from the date of enrollment (Day 1) to the date of first evidence of PSA progression. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase and an absolute increase of 2 nanogram (ng)/milliliter (mL) or more, which is confirmed by a second value obtained in 3 or more weeks. | Maximum up to Month 30.5 |
| Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment | Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed. Decrease in PSA levels represented improvement. | End of Cycle 3 (Approximately Month 3) |
| Huntsville |
| Alabama |
| United States |
| Tucson | Arizona | United States |
| Los Angeles | California | United States |
| San Diego | California | United States |
| San Francisco | California | United States |
| Aurora | Colorado | United States |
| Denver | Colorado | United States |
| Aventura | Florida | United States |
| Orange City | Florida | United States |
| Atlanta | Georgia | United States |
| Evanston | Illinois | United States |
| Galesburg | Illinois | United States |
| Glenview | Illinois | United States |
| Melrose Park | Illinois | United States |
| Fort Wayne | Indiana | United States |
| Jeffersonville | Indiana | United States |
| New Orleans | Louisiana | United States |
| Baltimore | Maryland | United States |
| Rockville | Maryland | United States |
| Boston | Massachusetts | United States |
| Lansing | Michigan | United States |
| Omaha | Nebraska | United States |
| Lawrenceville | New Jersey | United States |
| Albany | New York | United States |
| Brooklyn | New York | United States |
| Buffalo | New York | United States |
| Garden City | New York | United States |
| New York | New York | United States |
| Poughkeepsie | New York | United States |
| Staten Island | New York | United States |
| Chapel Hill | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Lancaster | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Greenville | South Carolina | United States |
| Myrtle Beach | South Carolina | United States |
| Nashville | Tennessee | United States |
| Arlington | Texas | United States |
| Houston | Texas | United States |
| Seattle | Washington | United States |
| Milwaukee | Wisconsin | United States |
| Completed Until Treatment Cycle 6 |
|
| COMPLETED | Completed refers to patients at clinical cut-off with no evidence of disease progression who continued on treatment whereas Not Completed refers to patients who discontinued treatment. |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Abiraterone Acetate Plus Prednisone | Participants were given abiraterone acetate 1000 milligrams (mg) (4*250 mg) tablets plus prednisone 5 mg (2*2.5 mg) tablets orally once daily in core study treatment phase (comprised of 6, 28-day cycles). After the core study treatment phase, participants who entered the pre-metastatic disease follow-up phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial. As per amendment 6, participants who opted for the drug holiday phase stopped abiraterone acetate plus prednisone, and androgen-deprivation therapy (ADT), with the option to restart treatment within the first year if prostate-specific antigen (PSA) levels increased without metastasis. Those who did not opt for the drug holiday phase continued treatment. The study ended when all participants had disease progression or completed the 2-year period (for drug holiday participants) (up to 140 months; 153 Cycles). Post-metastatic disease follow-up phase was also discontinued, though participants already enrolled at the time of protocol amendment 6 remained on study. A safety follow-up visit was required 30 days after the last dose of abiraterone acetate. |
| 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 |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study | Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed. | Efficacy evaluable set included all participants who received at least one dose of study drug, completed at least 1 cycle of treatment and had at least 1 post-baseline PSA assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | End of core study visit (Approximately at Month 6) |
|
|
| |||||||||||||||||||||||||
| Secondary | Time to Radiographic Evidence of Disease Progression (TTRP) | Time to radiographic evidence of disease progression is defined as the time interval from the date of enrollment (Day 1) to the date of disease progression. A participant was considered as progressed by bone scan if: 1) The appearance of greater than or equal to (>=) 2 new lesions, and, following the first assessment, a confirmatory scan performed 6 or more weeks later that shows a minimum of 2 or more additional new lesions, 2) If >=2 new lesions are seen on scans following the first assessment, the confirmation is still required after 6 weeks; however, 2 addition lesions are not required to confirm progression, and 3) The date of progression is the date of the first scan that shows the changes. | All enrolled set included all participants who received at least 1 dose of study drug. | Posted | Median | 95% Confidence Interval | Months | Maximum up to Month 30.5 |
| |||||||||||||||||||||||||||
| Secondary | Time to Prostate-Specific Antigen (PSA) Progression | Time to PSA progression is defined as the time interval from the date of enrollment (Day 1) to the date of first evidence of PSA progression. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase and an absolute increase of 2 nanogram (ng)/milliliter (mL) or more, which is confirmed by a second value obtained in 3 or more weeks. | All enrolled set included all participants who received at least 1 dose of study drug. | Posted | Median | 95% Confidence Interval | Months | Maximum up to Month 30.5 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment | Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed. Decrease in PSA levels represented improvement. | Efficacy evaluable set included all participants who received at least 1 dose of study drug, completed at least 1 cycle of treatment and had at least 1 post-baseline PSA assessment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | End of Cycle 3 (Approximately Month 3) |
|
All-cause mortality: From screening (-28 days) up to 141 months; Serious and Other AEs: From Cycle 1 Day 1 up to 30 days after last dose (up to 141 months)
Safety evaluable set defined as all participants exposed to study agents (Abiraterone acetate or Prednisone).
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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 | Abiraterone Acetate Plus Prednisone | Participants were given abiraterone acetate 1000 milligrams (mg) (4*250 mg) tablets plus prednisone 5 mg (2*2.5 mg) tablets orally once daily in core study treatment phase (comprised of 6, 28-day cycles). After the core study treatment phase, participants who entered the pre-metastatic disease follow-up phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator's decision, and withdrawal by participant or until the sponsor decided to stop the trial. As per amendment 6, participants who opted for the drug holiday phase stopped abiraterone acetate plus prednisone, and androgen-deprivation therapy (ADT), with the option to restart treatment within the first year if prostate-specific antigen (PSA) levels increased without metastasis. Those who did not opt for the drug holiday phase continued treatment. The study ended when all participants had disease progression or completed the 2-year period (for drug holiday participants) (up to 140 months; 153 Cycles). Post-metastatic disease follow-up phase was also discontinued, though participants already enrolled at the time of protocol amendment 6 remained on study. A safety follow-up visit was required 30 days after the last dose of abiraterone acetate. | 11 | 131 | 61 | 131 | 120 | 131 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Meniere's Disease | Ear and labyrinth disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Adrenal Mass | Endocrine disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Colitis Ulcerative | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Gastrointestinal Pain | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Obstruction Gastric | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Rectourethral Fistula | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Systemic Inflammatory Response Syndrome | General disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Chest Wall Abscess | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Escherichia Urinary Tract Infection | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Giardiasis | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Lobar Pneumonia | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Lung Infection | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Postoperative Wound Infection | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Cystitis Radiation | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Multiple Injuries | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Transplant Failure | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Blood Glucose Increased | Investigations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Blood Potassium Increased | Investigations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Hepatic Enzyme Increased | Investigations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Liver Function Test Abnormal | Investigations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Electrolyte Imbalance | Metabolism and nutrition disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Failure to Thrive | Metabolism and nutrition disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Lactic Acidosis | Metabolism and nutrition disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Balance Disorder | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Brain Mass | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Neurological Symptom | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Acute Psychosis | Psychiatric disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Bladder Obstruction | Renal and urinary disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Obstructive Uropathy | Renal and urinary disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Urinary Tract Obstruction | Renal and urinary disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Nephrectomy | Surgical and medical procedures | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Transurethral Prostatectomy | Surgical and medical procedures | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Peripheral Circulatory Failure | Vascular disorders | MedDRA Version 14.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Micturition Urgency | Renal and urinary disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Urinary Incontinence | Renal and urinary disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 14.0 | Non-systematic Assessment |
|
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days. The sponsor will not mandate modifications to scientific content and does not have the right to suppress information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Janssen Services, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 21, 2014 | Dec 1, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069501 | Abiraterone Acetate |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Hispanic or Latino |
|
|
|
|
|
|
|