Prostate Cancer
Conditions
Keywords
Prostate cancer, Abiraterone acetate, Leuprolide acetate, Prednisone, CB7630, Testosterone
Brief summary
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).
Detailed description
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.
Interventions
DRUGAbiraterone
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.
DRUGLeuprolide
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.
DRUGPrednisone
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.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed adenocarcinoma of the prostate * At least three core biopsies positive for prostate cancer (a minimum of 6 core biopsies must be obtained at baseline). A prostate biopsy within 6 months from Screening is allowed for entry requirements * At least one of the following features: prostate specific antigen (PSA) greater than (\>) 10 nanogram per milliliter (ng/ml); PSA velocity \>2 ng/ml per /year (defined as a rise in PSA of \>2 ng/ml in the preceding 12 month period); Gleason score greater than or equal to (\>=) 7 (4+3); Gleason score 6 if either PSA \>=10 ng/ml or PSA velocity \>=2 ng/ml/year * Serum testosterone \>200 nanogram/deciliter * Participant and urologist must agree that participant is suitable for prostatectomy
Exclusion criteria
* Serious or uncontrolled co-existent, non-malignant disease, including active and uncontrolled infection * Abnormal liver function consisting of any of the following: serum bilirubin \>= 1.5 \* upper limit of normal (ULN); aspartate aminotransferase or alanine aminotransferase \>=2.5 \* ULN * Uncontrolled hypertension within the Screening period (systolic blood pressure \>= 160 millimeter of mercury \[mmHg\] or diastolic BP \>= 95 mmHg) * Requirement for corticosteroids greater than the equivalent of 5 milligram of prednisone daily * Participants with active or symptomatic viral hepatitis or chronic liver disease or clinically significant heart disease or as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of \< 50 percent at Baseline or history of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug or history of pituitary or adrenal dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Testosterone Concentration in Prostate Tissue | Week 12 | 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. |
| Dihydrotestosterone (DHT) Concentration in Prostate Tissue | Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Levels of Androgens | Week 12 and 24 | Serum concentrations of testosterone, DHT, androsterone, DHEA, DHEA-Sulfate, DHEA-Glucuronide and delta-4-androstenedione were measured at Weeks 12 and 24. |
| Percentage of Participants With Prostate-specific Antigen (PSA) Response | Weeks 12 and 24 | 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. |
| Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue | Week 24 | 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. |
| Number of Participants With Tumor Expression of Androgen Receptor (AR) Regulated Genes at Week 24 | 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. |
| Correlation Between Molecular and Protein Expression With Intracellular Androgen Levels and Pathologic Response to Study Treatment | Week 24 | Molecular and protein expression was correlated with intracellular androgen levels and pathologic response to study treatment. |
| Percentage of Participants With Pathologic Complete Response (CR) | Week 24 | Complete response is defined as a disappearance of all target lesions and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criterion. |
| Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue | Week 12 and 24 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 28 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Abiraterone Plus Leuprolide Plus Prednisone | Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Total |
|---|---|---|---|
| Age Continuous | 61.0 years STANDARD_DEVIATION 6.67 | 56.9 years STANDARD_DEVIATION 5.3 | 59.0 years STANDARD_DEVIATION 6.35 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 30 Participants | 28 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 30 / 30 | 28 / 28 |
| serious Total, serious adverse events | 6 / 30 | 7 / 28 |
Outcome results
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.
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abiraterone Plus Leuprolide Plus Prednisone | Dihydrotestosterone (DHT) Concentration in Prostate Tissue | 4.311 Picogram per milligram (pg/mg) | Standard Deviation 21.6213 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Dihydrotestosterone (DHT) Concentration in Prostate Tissue | 2.170 Picogram per milligram (pg/mg) | Standard Deviation 3.4589 |
Comparison: Statistical Analysis 2 for DHT concentration at Week 12p-value: <0.000190% CI: [0.098, 0.289]ANOVA
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.
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abiraterone Plus Leuprolide Plus Prednisone | Testosterone Concentration in Prostate Tissue | 0.089 Picogram per milligram (pg/mg) | Standard Deviation 0.0637 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Testosterone Concentration in Prostate Tissue | 0.228 Picogram per milligram (pg/mg) | Standard Deviation 0.3788 |
Comparison: Statistical Analysis 1 for testosterone concentration at Week 12p-value: 0.021690% CI: [0.429, 0.865]ANOVA
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.
Time frame: Week 12 and 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abiraterone Plus Leuprolide Plus Prednisone | Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue | Androstenedione: Week 12 (n=28,27) | 0.082 Picogram per milligram (pg/mg) | Standard Deviation 0.0525 |
| Abiraterone Plus Leuprolide Plus Prednisone | Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue | Androstenedione: Week 24 (n=28,26) | 0.090 Picogram per milligram (pg/mg) | Standard Deviation 0.0879 |
| Abiraterone Plus Leuprolide Plus Prednisone | Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue | DHEA: Week 12 (n=28,27) | 1.994 Picogram per milligram (pg/mg) | Standard Deviation 5.0266 |
| Abiraterone Plus Leuprolide Plus Prednisone | Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue | DHEA: Week 24 (n=28,26) | 3.138 Picogram per milligram (pg/mg) | Standard Deviation 8.6692 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue | DHEA: Week 24 (n=28,26) | 2.170 Picogram per milligram (pg/mg) | Standard Deviation 3.7095 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue | Androstenedione: Week 12 (n=28,27) | 0.277 Picogram per milligram (pg/mg) | Standard Deviation 0.1729 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue | DHEA: Week 12 (n=28,27) | 29.241 Picogram per milligram (pg/mg) | Standard Deviation 26.98 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue | Androstenedione: Week 24 (n=28,26) | 0.070 Picogram per milligram (pg/mg) | Standard Deviation 0.0403 |
Comparison: Statistical Analysis 1 for androstenedione concentration at Week 12p-value: <0.000190% CI: [0.239, 0.418]ANOVA
Comparison: Statistical Analysis 2 for androstenedione concentration at Week 24p-value: 0.506190% CI: [0.828, 1.554]ANOVA
Comparison: Statistical Analysis 3 for DHEA concentration at Week 12p-value: <0.000190% CI: [0.017, 0.05]ANOVA
Comparison: Statistical Analysis 4 for DHEA concentration at Week 24p-value: 0.576790% CI: [0.398, 1.581]ANOVA
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.
Time frame: Week 24
Population: Resullts were not reported due to insufficient data in this outcome measure.
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.
Time frame: Week 24
Population: Resullts were not reported due to insufficient data in this outcome measure.
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.
Time frame: Week 24
Population: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Abiraterone Plus Leuprolide Plus Prednisone | Percentage of Participants With Pathologic Complete Response (CR) | 10.3 Percentage of participants | 0.0637 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Percentage of Participants With Pathologic Complete Response (CR) | 3.7 Percentage of participants | 0.3788 |
Comparison: Statistical Analysis 1 for CR at Week 24p-value: 0.342790% CI: [1.018, 5.015]Cochran-Mantel-Haenszel
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.
Time frame: Weeks 12 and 24
Population: ITT population included all the participants who were randomly assigned to the study treatment.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Abiraterone Plus Leuprolide Plus Prednisone | Percentage of Participants With Prostate-specific Antigen (PSA) Response | Week 12 | 86.7 Percentage of participants | 0.0637 |
| Abiraterone Plus Leuprolide Plus Prednisone | Percentage of Participants With Prostate-specific Antigen (PSA) Response | Week 24 | 86.7 Percentage of participants | — |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Percentage of Participants With Prostate-specific Antigen (PSA) Response | Week 12 | 3.6 Percentage of participants | 0.3788 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Percentage of Participants With Prostate-specific Antigen (PSA) Response | Week 24 | 82.1 Percentage of participants | — |
Comparison: Statistical Analysis 1 for PSA response at Week 12p-value: <0.000190% CI: [4.989, 130.68]Cochran-Mantel-Haenszel
Comparison: Statistical Analysis 2 for PSA response at Week 24p-value: 0.231990% CI: [0.956, 1.337]Cochran-Mantel-Haenszel
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.
Time frame: Week 12 and 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | DHT: Week 24 (n=26,26) | 5.932 Nanogram per deciliter (ng/dL) | Standard Deviation 9.1599 |
| Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | DHEA: Week 24 (n=26,26) | 20.922 Nanogram per deciliter (ng/dL) | Standard Deviation 64.2594 |
| Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | Testosterone: Week 12 (n=28,28) | 1.049 Nanogram per deciliter (ng/dL) | Standard Deviation 1.0374 |
| Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | DHEA-Glucuronide: Week 12 (n=29,28) | 69.724 Nanogram per deciliter (ng/dL) | Standard Deviation 184.2399 |
| Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | Androsterone: Week 12 (n=28,28) | 0.619 Nanogram per deciliter (ng/dL) | Standard Deviation 0.4473 |
| Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | DHEA-Glucuronide: Week 24 (n=27,27) | 51.675 Nanogram per deciliter (ng/dL) | Standard Deviation 148.9412 |
| Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | DHT: Week 12 (n=28,28) | 6.143 Nanogram per deciliter (ng/dL) | Standard Deviation 8.9868 |
| Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | DHEA-Sulfate: Week 12 (n=28,28) | 7156.270 Nanogram per deciliter (ng/dL) | Standard Deviation 22406.7048 |
| Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | Androsterone: Week 24 (26,26) | 1.752 Nanogram per deciliter (ng/dL) | Standard Deviation 6.3226 |
| Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | DHEA-Sulfate: Week 24 (n=26,26) | 9047.406 Nanogram per deciliter (ng/dL) | Standard Deviation 27844.7883 |
| Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | Testosterone: Week 24 (n=25,25) | 0.648 Nanogram per deciliter (ng/dL) | Standard Deviation 0.4975 |
| Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | Delta-4-Androstenedione:Week 12(n=28,28) | 3.315 Nanogram per deciliter (ng/dL) | Standard Deviation 3.3858 |
| Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | DHEA: Week 12 (n=28,28) | 10.684 Nanogram per deciliter (ng/dL) | Standard Deviation 27.2814 |
| Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | Delta-4-Androstenedione:Week 24(n=26,26) | 5.192 Nanogram per deciliter (ng/dL) | Standard Deviation 10.8654 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | DHEA: Week 12 (n=28,28) | 180.307 Nanogram per deciliter (ng/dL) | Standard Deviation 133.6277 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | Testosterone: Week 12 (n=28,28) | 10.014 Nanogram per deciliter (ng/dL) | Standard Deviation 12.5981 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | Testosterone: Week 24 (n=25,25) | 3.122 Nanogram per deciliter (ng/dL) | Standard Deviation 12.646 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | DHT: Week 12 (n=28,28) | 5.797 Nanogram per deciliter (ng/dL) | Standard Deviation 5.9816 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | DHT: Week 24 (n=26,26) | 6.730 Nanogram per deciliter (ng/dL) | Standard Deviation 15.7929 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | Androsterone: Week 12 (n=28,28) | 3.100 Nanogram per deciliter (ng/dL) | Standard Deviation 5.8891 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | Androsterone: Week 24 (26,26) | 0.500 Nanogram per deciliter (ng/dL) | Standard Deviation 0 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | Delta-4-Androstenedione:Week 24(n=26,26) | 2.831 Nanogram per deciliter (ng/dL) | Standard Deviation 1.1596 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | DHEA: Week 24 (n=26,26) | 7.617 Nanogram per deciliter (ng/dL) | Standard Deviation 14.5386 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | DHEA-Glucuronide: Week 12 (n=29,28) | 583.036 Nanogram per deciliter (ng/dL) | Standard Deviation 879.7514 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | DHEA-Glucuronide: Week 24 (n=27,27) | 51.759 Nanogram per deciliter (ng/dL) | Standard Deviation 95.0666 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | DHEA-Sulfate: Week 12 (n=28,28) | 133338.875 Nanogram per deciliter (ng/dL) | Standard Deviation 108819.6403 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | DHEA-Sulfate: Week 24 (n=26,26) | 9207.345 Nanogram per deciliter (ng/dL) | Standard Deviation 30897.5488 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Serum Levels of Androgens | Delta-4-Androstenedione:Week 12(n=28,28) | 33.330 Nanogram per deciliter (ng/dL) | Standard Deviation 26.811 |
Comparison: Statistical Analysis 1 for serum testosterone concentration at Week 12p-value: <0.000190% CI: [0.097, 0.207]ANCOVA
Comparison: Statistical Analysis 2 for serum testosterone concentration at Week 24p-value: 0.436490% CI: [0.571, 1.225]ANCOVA
Comparison: Statistical Analysis 3 for serum DHT concentration at Week 12p-value: 0.151590% CI: [0.54, 1.044]ANCOVA
Comparison: Statistical Analysis 4 for serum DHT concentration at Week 24p-value: 0.396590% CI: [0.589, 1.188]ANCOVA
Comparison: Statistical Analysis 5 for serum Androsterone concentration at Week 12p-value: 0.000390% CI: [0.29, 0.615]ANCOVA
Comparison: Statistical Analysis 6 for serum androsterone concentration at Week 24p-value: 0.249490% CI: [0.916, 1.625]ANCOVA
Comparison: Statistical Analysis 7 for serum DHEA concentration at Week 12p-value: <0.000190% CI: [0.023, 0.073]ANCOVA
Comparison: Statistical Analysis 8 for serum DHEA concentration at Week 24p-value: 0.514490% CI: [0.717, 2.137]ANCOVA
Comparison: Statistical Analysis 9 for serum DHEA-glucuronide concentration at Week 12p-value: <0.000190% CI: [0.055, 0.189]ANCOVA
Comparison: Statistical Analysis 10 for serum DHEA-glucuronide concentration at Week 24p-value: 0.132990% CI: [0.286, 1.06]ANCOVA
Comparison: Statistical Analysis 11 for serum DHEA-sulfate concentration at Week 12p-value: <0.000190% CI: [0.008, 0.028]ANCOVA
Comparison: Statistical Analysis 12 for serum DHEA-sulfate concentration at Week 24p-value: 0.706190% CI: [0.53, 2.73]ANCOVA
Comparison: Statistical Analysis 13 for serum delta-4-androstenedione concentration at Week 12p-value: <0.000190% CI: [0.29, 0.615]ANCOVA
Comparison: Statistical Analysis 14 for serum delta-4-androstenedione concentration at Week 24p-value: 0.267390% CI: [0.916, 1.625]ANCOVA
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.
Time frame: Week 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abiraterone Plus Leuprolide Plus Prednisone | Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue | Testosterone | 0.216 Picogram per milligram (pg/mg) | Standard Deviation 0.6707 |
| Abiraterone Plus Leuprolide Plus Prednisone | Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue | DHT | 1.340 Picogram per milligram (pg/mg) | Standard Deviation 3.5099 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue | Testosterone | 0.062 Picogram per milligram (pg/mg) | Standard Deviation 0.034 |
| Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone | Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue | DHT | 2.456 Picogram per milligram (pg/mg) | Standard Deviation 6.3901 |
Comparison: Statistical Analysis 1 for testosterone concentration at Week 24p-value: 0.142390% CI: [0.956, 2.145]ANOVA
Comparison: Statistical Analysis 2 for DHT concentration at Week 24p-value: 0.663990% CI: [0.386, 1.746]ANOVA