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| ID | Type | Description | Link |
|---|---|---|---|
| COU-AA-201 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate safety and efficacy of abiraterone acetate plus leuprolide acetate and prednisone, versus leuprolide acetate alone in male participants with prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, forming tumors) who are suitable candidates for prostatectomy (surgery to remove all or part of the prostate gland).
This is an open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), and multi-center (conducted in more than one center) study of abiraterone in male participants with prostate cancer. The duration of study will be approximately 24-32 weeks per participant. The study consists of 4 parts: Screening (that is, 30 days before study commences on Day 1); Treatment (abiraterone acetate 1000 milligram per day or leuprolide acetate as 22.5 milligram intramuscular injection [injection of a substance into a muscle] or prednisone 5 mg once daily); Prostatectomy (Week 24); and Follow-up ( 4-8 weeks after prostatectomy). Participants will receive either abiraterone, leuprolide and prednisone for 24 weeks (that is, Group 1) or leuprolide once every 12 weeks up to Week 24 then abiraterone and prednisone from Week 13 to 24 (that is, Group 2). All the eligible participants will be randomly assigned to 1 of the 2 treatment groups. Efficacy will be evaluated primarily through the concentrations of testosterone and dihydrotestosterone from prostate tissues at Week 12. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abiraterone plus leuprolide plus prednisone | Experimental | Abiraterone acetate tablets will be administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate will be administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone tablets will be administered orally as 5 mg once daily for 24 weeks. |
|
| Leuprolide then abiraterone plus leuprolide plus prednisone | Active Comparator | Leuprolide acetate will be administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets will be administered orally at a total dose of 1000 mg per day with prednisone tablets administered orally as 5 mg once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone | Drug | Abiraterone acetate tablets will be administered orally at a total dose of 1000 milligram (mg) per day at least 1 hour before a meal or 2 hours after a meal for 24 weeks in Group 1 and from Week 13 to Week 24 for Group 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Testosterone Concentration in Prostate Tissue | Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Abiraterone acetate affects sources of testosterone in the body (ie, adrendal gland and prostate tumor). Testosterone concentration was measured in prostate tissues after exposure to study treatments at Week 12. | Week 12 |
| Dihydrotestosterone (DHT) Concentration in Prostate Tissue | The DHT is a potent androgenic metabolite of testosterone and the concentration of DHT was measured in prostate tissues after exposure to study treatments at Week 12. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue | Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Dihydrotestosterone (DHT) is a potent androgenic metabolite of testosterone. Testosterone and DHT concentration was measured in prostate tissues after exposure to study treatments at Week 24. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston | Massachusetts | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Abiraterone Plus Leuprolide Plus Prednisone | Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Leuprolide | Drug | Leuprolide acetate will be administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks in Group 1 and Group 2. |
|
| Prednisone | Drug | Prednisone tablets will be administered orally as 5 mg once daily for 24 weeks in Group 1 and from Week 13 to Week 24 for Group 2. |
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| Week 24 |
| Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue | Androstenedione is a steroid (a group of polycyclic compounds closely related biochemically to terpenes, for example, cholesterol, numerous hormones), that is produced in the testis, ovary and the adrenal cortex, and depending on the tissue type, androstenedione can serve as a precursor to testosterone, estrone and estradiol. The DHEA is a major steroid produced by the adrenal cortex. It is also produced in small quantities in the testis and the ovary. Androstenedione and DHEA concentration was measured in prostate tissues at Week 12 and 24. | Week 12 and 24 |
| Serum Levels of Androgens | Serum concentrations of testosterone, DHT, androsterone, DHEA, DHEA-Sulfate, DHEA-Glucuronide and delta-4-androstenedione were measured at Weeks 12 and 24. | Week 12 and 24 |
| Percentage of Participants With Prostate-specific Antigen (PSA) Response | The PSA response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criterion which is, percentage of participants with PSA less than or equal to 0.2 nanogram/milliliter at Weeks 12 and 24 after androgen deprivation. | Weeks 12 and 24 |
| Percentage of Participants With Pathologic Complete Response (CR) | Complete response is defined as a disappearance of all target lesions and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criterion. | Week 24 |
| Number of Participants With Tumor Expression of Androgen Receptor (AR) Regulated Genes at Week 24 | Tumor expression of AR regulated genes determined by real-time polymerase chain reaction (RT PCR). PCR is an in vitro method for producing large amounts of specific deoxyribonucleic acid (DNA) or ribonucleic acid fragments of defined length and sequence from small amounts of short oligonucleotide flanking sequences (primers). RT PCR is a method used for detecting the amplified DNA products from the PCR as they accumulate instead of at the end of the reaction. | Week 24 |
| Correlation Between Molecular and Protein Expression With Intracellular Androgen Levels and Pathologic Response to Study Treatment | Molecular and protein expression was correlated with intracellular androgen levels and pathologic response to study treatment. | Week 24 |
| Houston |
| Texas |
| United States |
| Seattle | Washington | United States |
| Wenatchee | Washington | United States |
| FG001 | Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Abiraterone Plus Leuprolide Plus Prednisone | Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks. |
| BG001 | Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | 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 | Testosterone Concentration in Prostate Tissue | Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Abiraterone acetate affects sources of testosterone in the body (ie, adrendal gland and prostate tumor). Testosterone concentration was measured in prostate tissues after exposure to study treatments at Week 12. | Intent-to-treat (ITT) population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | Picogram per milligram (pg/mg) | Week 12 |
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| Secondary | Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue | Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Dihydrotestosterone (DHT) is a potent androgenic metabolite of testosterone. Testosterone and DHT concentration was measured in prostate tissues after exposure to study treatments at Week 24. | ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | Picogram per milligram (pg/mg) | Week 24 |
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| Secondary | Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue | Androstenedione is a steroid (a group of polycyclic compounds closely related biochemically to terpenes, for example, cholesterol, numerous hormones), that is produced in the testis, ovary and the adrenal cortex, and depending on the tissue type, androstenedione can serve as a precursor to testosterone, estrone and estradiol. The DHEA is a major steroid produced by the adrenal cortex. It is also produced in small quantities in the testis and the ovary. Androstenedione and DHEA concentration was measured in prostate tissues at Week 12 and 24. | ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure and "n" signifies those participants who were evaluated for this measure at the specified time point. | Posted | Mean | Standard Deviation | Picogram per milligram (pg/mg) | Week 12 and 24 |
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| Secondary | Serum Levels of Androgens | Serum concentrations of testosterone, DHT, androsterone, DHEA, DHEA-Sulfate, DHEA-Glucuronide and delta-4-androstenedione were measured at Weeks 12 and 24. | ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure and "n" signifies those participants who were evaluated for this measure at the specified time point. | Posted | Mean | Standard Deviation | Nanogram per deciliter (ng/dL) | Week 12 and 24 |
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| Secondary | Percentage of Participants With Prostate-specific Antigen (PSA) Response | The PSA response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criterion which is, percentage of participants with PSA less than or equal to 0.2 nanogram/milliliter at Weeks 12 and 24 after androgen deprivation. | ITT population included all the participants who were randomly assigned to the study treatment. | Posted | Number | Percentage of participants | Weeks 12 and 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Pathologic Complete Response (CR) | Complete response is defined as a disappearance of all target lesions and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criterion. | ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Number | Percentage of participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Tumor Expression of Androgen Receptor (AR) Regulated Genes at Week 24 | Tumor expression of AR regulated genes determined by real-time polymerase chain reaction (RT PCR). PCR is an in vitro method for producing large amounts of specific deoxyribonucleic acid (DNA) or ribonucleic acid fragments of defined length and sequence from small amounts of short oligonucleotide flanking sequences (primers). RT PCR is a method used for detecting the amplified DNA products from the PCR as they accumulate instead of at the end of the reaction. | Resullts were not reported due to insufficient data in this outcome measure. | Posted | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Correlation Between Molecular and Protein Expression With Intracellular Androgen Levels and Pathologic Response to Study Treatment | Molecular and protein expression was correlated with intracellular androgen levels and pathologic response to study treatment. | Resullts were not reported due to insufficient data in this outcome measure. | Posted | Week 24 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Dihydrotestosterone (DHT) Concentration in Prostate Tissue | The DHT is a potent androgenic metabolite of testosterone and the concentration of DHT was measured in prostate tissues after exposure to study treatments at Week 12. | Intent-to-treat (ITT) population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | Picogram per milligram (pg/mg) | Week 12 |
|
Baseline up to Week 32
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
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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 Plus Leuprolide Plus Prednisone | Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks. | 6 | 30 | 30 | 30 | ||
| EG001 | Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily. | 7 | 28 | 28 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pituitary infarction | Endocrine disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Hernia obstructive | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Infected lymphocele | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Renal injury | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Gynaecomastia | Endocrine disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Irritability | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Libido decreased | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Loss of libido | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Mood altered | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Mood swings | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Nocturia | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Urine flow decreased | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Erectile dysfunction | Reproductive system and breast disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Testicular pain | Reproductive system and breast disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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Sponsor will retain the right to review all material prior to presentation or submission for publication and neither institution(s) nor Study Co-Chairs/Principal Investigator(s) is/are permitted to publish/present the results of the study, in part or in their entirety, without the written authorization of the Sponsor. The review is aimed at complying with 21CFR312.7 (non promotion of investigational drugs) as well as the intellectual property rights and commercial interests of the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Clinical Research | Janssen Research & Development, LLC 10990 Wilshire Blvd, Suite 1200 Los Angeles, CA 90024 | (310) 914-2917 |
| 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 |
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Not provided
| ID | Term |
|---|---|
| C089740 | abiraterone |
| D000069501 | Abiraterone Acetate |
| D016729 | Leuprolide |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
Not provided
Not provided
| Male |
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Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily. |
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