Prostate Cancer
Conditions
Keywords
Drug therapy
Brief summary
The purpose of this study is to evaluate the efficacy of TAK-385 for achieving and maintaining testosterone suppression.
Detailed description
The drug being tested in this study is called TAK-385. Men with prostate cancer benefit from receiving androgen deprivation therapy (ADT) to minimize testosterone levels before, during and after EBRT. This combination increases the potential success of treating their disease. This study will see if TAK-385 \[an oral gonadotropin-releasing hormone (GnRH) antagonist\] brings testosterone levels down sufficiently, with the convenience and comfort of taking a pill. It will look at the time it takes to restore testosterone levels after radiation therapy as well. One hundred participants will be assigned by chance (like flipping a coin) to a treatment group: 60 to TAK-385, and 40 to degarelix. Those assigned to TAK-385 will take a daily pill. Those assigned to degarelix will receive an injection under the skin once every four weeks at the clinic. They will start radiation therapy when testosterone is low enough, after at least 12 weeks of treatment. This trial will be conducted at clinics in the United States (US) and United Kingdom (UK). Participants will visit the clinic up to 14 times over 37 weeks for physical exams and blood tests, and might receive one follow-up telephone call.
Interventions
DRUGTAK-385
TAK-385 tablet
DRUGDegarelix
Degarelix injection
Sponsors
Millennium Pharmaceuticals, Inc.
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
1. Is male, 18 years of age or older. 2. Has histologically confirmed diagnosis of localized prostate adenocarcinoma of intermediate risk for which 6-month neoadjuvant and adjuvant androgen deprivation therapy (ADT) to EBRT is indicated. Intermediate risk per National Comprehensive Cancer Network (NCCN) guidelines includes one of the following: 1. T2b-T2c disease, or 2. Gleason score 7, or 3. Prostate-specific antigen (PSA) 10-20 nanogram per milliliter (ng/mL). 3. Is scheduled for EBRT to begin greater than or equal to (\>=) 12 weeks after the Baseline visit. 4. Has serum testosterone at screening greater then (\>) 150 nanogram per deciliter (ng/dL) (5.2 nanomoles per liter \[nmol/L\]). 5. Has screening serum PSA concentration \>2 ng/mL. 6. Has body mass index (BMI) \>=18.0 at screening or baseline. 7. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening or baseline. 8. Is a male participant, even if surgically sterilized (that is, status postvasectomy), who: Agrees to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or, Agrees to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \[example, calendar, ovulation, symptothermal, postovulation methods for the female partner\] and withdrawal are not acceptable methods of contraception.). 9. Has given voluntary written consent before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care. 10. Has suitable venous access for the study-required blood sampling, including pharmacokinetic (PK) and pharmacodynamic sampling.
Exclusion criteria
1. Has metastatic disease (based on investigator evaluation and assuming no likely metastatic pelvic lymph nodes \>1.0 cm in long axis diameter). 2. Had prior or current use of a gonadotropin-releasing hormone (GnRH) analog or androgen receptor antagonist as first-line hormone therapy, unless total use was less than 6 months and not more recently than 1 year before the planned baseline visit. 3. Had diagnosis of or treatment for another malignancy within 2 years before the first dose of study drug, or previous diagnosis of another malignancy with evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. 4. Has abnormal screening and/or baseline laboratory values that suggest a clinically significant underlying disease, or the following laboratory values: 1. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>1.5 \* institutional upper limit of the normal range (ULN); 2. Serum creatinine \>2.0 milligram per deciliter (mg/dL); 3. Total bilirubin \>2.0 \* institutional ULN (unless documented Gilbert's disease); 4. Uncontrolled diabetes (Hemoglobin A1c \[HbA1c\] \>10 \[percent\] %) or previously undiagnosed diabetes mellitus with HbA1c \>8%. 5. Has history of myocardial infarction, unstable symptomatic ischemic heart disease, any ongoing cardiac arrhythmias of Grade \>2 (chronic stable atrial fibrillation on stable anticoagulant therapy is allowed), thromboembolic events (example, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other significant cardiac condition (example, pericardial effusion, restrictive cardiomyopathy) within 6 months before receiving the first dose of study drug. 6. Has electrocardiogram (ECG) abnormalities of: 1. Q-wave infarction, unless identified 6 or more months before screening; 2. Heart rate-corrected QT interval millisecond (msec) (QTcF interval) \>480 msec. If QTcF is prolonged in a participant with a pacemaker, the participant may be enrolled in the study upon discussion with the project clinician; 3. If the QTcF interval is 450-480 msec, inclusive, in a participant with current use of medications with known effects on QT interval, the participant may be enrolled in the study following discussion with the project clinician. 7. Has congenital long QT syndrome. 8. Is currently using Class IA (example, quinidine, procainamide) or Class III (example, amiodarone, sotalol) antiarrhythmic medications. 9. Has uncontrolled hypertension despite appropriate medical therapy (sitting blood pressure \[BP\] of greater than 160 millimeters of mercury (mmHg) systolic and 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the Screening visit). Participants with systolic BP measurements \>160 mmHg may be rescreened. Participants with systolic BP measurements 141-160 mmHg, although eligible, should be referred for further management of hypertension if indicated. 10. Has known, previously diagnosed human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C, life-threatening illness unrelated to prostate cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study. Specific screening for chronic viral illness is at the discretion of the site and/or local institutional review board (IRB). 11. Has received treatment with any investigational products within 3 months before the first dose of study drug. 12. Is a primary family member (spouse, parent, child, or sibling) of anyone involved in the conduct of the study or is a study site employee. 13. Has known gastrointestinal (GI) disease, condition or procedure that could interfere with the oral absorption or tolerance of TAK-385, including difficulty swallowing tablets. 14. Is using any medication or food products listed in the excluded medications and dietary products table within 2 weeks before the first dose of study drug. This list includes moderate and strong inhibitors or inducers of cytochrome P450 (CYP3A4/5) and P-glycoprotein (P-gp). Participants must have no history of amiodarone use in the 6 months before the first dose of TAK-385. 15. Has admission or evidence of alcohol or drug abuse or use of illicit drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Effective Castration Rate Over 25 Weeks | Day 1 Week 5 up to Day 1 Week 25 | Castration rate is defined as the observed percentage of participants who have testosterone concentrations less than (\<) 50 nanogram per deciliter (ng/dL) (1.73 nanomole per liter \[nmol/L\]) at all scheduled visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With TEAEs Related to Physical Findings | Baseline up to Week 29 | — |
| Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings | Baseline up to Week 29 | — |
| Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis | Baseline up to Week 29 | — |
| Number of Participants Reporting One or More TEAEs and Serious Adverse Events (SAEs) | Baseline up to Week 29 | — |
| Average Percent Change in Prostate Size | Baseline, Day 1 Week 9 to Day 1 Week 13 | Percent change in prostate size was assessed at a follow up visit between Day 1 Week 9 to Day 1 Week 13. |
| Time to Achieve Effective Castration | Baseline up to Week 37 | Time to effective castration is defined as days from first dose to first testosterone measurement that is \<50 ng/dL. |
| Time to Achieve Profound Castration | Baseline up to Week 37 | Time to profound castration is defined as days from first dose to first testosterone measurement that is \<20 ng/dL. |
| Estimated Time to Testosterone Recovery (TTR) | Up to Day 1 Week 37 | TTR is defined as the time from 1 day after the last dose of TAK-385 or 4 weeks plus 1 day after the last dose of degarelix to testosterone recovery. Testosterone recovery is defined as back to baseline or \>280 ng/dL whichever occurs first. TTR was determined during 12 weeks after the discontinuation of androgen deprivation therapy (ADT). |
| Percentage of Participants Who Have Recovered to Baseline Value of Testosterone | Up to Day 1 Week 37 | — |
| Percentage of Participants Who Have Recovered to >280 ng/dL Testosterone | Day 1 Week 25 up to Day 1 Week 37 | — |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs | Baseline up to Week 29 | — |
| Percent Change From Baseline in Serum PSA Concentration | Baseline, Day 1 of Week 2, 3 , 5, 9, 13, 17, 21, 25, 29, 33 and 37 | — |
| PSA Nadir | Baseline up to Day 1 Week 25 | — |
| Serum PSA Concentration | Day 1 of Week 13, 25, 29, 33 and 37 | — |
| Plasma Concentrations of TAK-385 | Day 1 Week 1, 2, 3, 5, 9, 13, 17, 25, 33, 37: Pre-dose; Day 1 Week 5, 13: 2 hrs Post-dose; Day 4 Week 1: Pre-dose | — |
| Serum Luteinizing Hormone (LH) Level | Baseline, Day 1 of Weeks 2, 3, 5, 9, 13, 17, 21, 25, 29, and 37 | — |
| Serum Follicle-Stimulating Hormone (FSH) Level | Baseline, Day 1 of Week 2, 5, 13, 25 and 29 | — |
| Serum Sex Hormone-Binding Globulin (SHBG) Level | Baseline, Day 1 of Week 2, 5, 13, 25 and 29 | — |
| Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score | Day 1 of Weeks 5, 13, 25, 29, 33 and 37 | AMS scale is a self-administered questionnaire used to 1) assess symptoms of aging (independent from those that are disease related) between groups of males under different conditions; 2) evaluate the severity of symptoms over time; and 3) measure changes before and after androgen therapy. Each question was answered between none (1) to extremely severe (5) for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total score is sum of all the item scores and range from 17 (minimum) to 85 (maximum), where high score indicated high level of symptoms. |
| Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score | Baseline and last post-baseline value up to Week 37 | EORTC QLQ-C30 included 30 questions comprising 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, nausea/vomiting), single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) and a global health and QOL scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'Very poor' to 7 'Excellent'). All domain scores were calculated as an average of item scores and transformed to 0-100 score range where a high score from 0-100 indicates: A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem. |
| Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | Baseline and last post-baseline value up to Week 37 | EORTC QLQ-PR25 : EORTC module designed to supplement the QLQ-C30 for any application in prostate cancer. It Consist of 25 questions distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual). |
| Number of Participants With PSA Response of >=50% and >=90% Reduction | Day 1 Week 13 | Prostate-specific Antigen (PSA) response was defined as 50% and 90% reduction from baseline in serum PSA levels. |
Countries
United Kingdom, United States
Participant flow
Recruitment details
Participants took part in the study at 23 investigative sites in the United States (US) and the United Kingdom (UK).
Pre-assignment details
Participants with a diagnosis of localized prostate cancer were enrolled in 1 of the 2 treatment groups to receive TAK-385 120 milligram (mg) or degarelix 80 mg.
Participants by arm
| Arm | Count |
|---|---|
| Experimental: TAK-385 120 mg TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24. | 65 |
| Experimental: Degarelix 80 mg Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21. | 38 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Experimental: TAK-385 120 mg | Total | Experimental: Degarelix 80 mg |
|---|---|---|---|
| Age, Customized 18 to 64 years | 9 participants | 16 participants | 7 participants |
| Age, Customized 65 to 84 years | 55 participants | 86 participants | 31 participants |
| Age, Customized Greater than or equal to (>=) 85 years | 1 participants | 1 participants | 0 participants |
| Diagnosis of Primary Tumor at Study entry Not available | 11 participants | 19 participants | 8 participants |
| Diagnosis of Primary Tumor at Study entry T1 | 1 participants | 2 participants | 1 participants |
| Diagnosis of Primary Tumor at Study entry T1a | 0 participants | 1 participants | 1 participants |
| Diagnosis of Primary Tumor at Study entry T1c | 20 participants | 30 participants | 10 participants |
| Diagnosis of Primary Tumor at Study entry T2 | 6 participants | 11 participants | 5 participants |
| Diagnosis of Primary Tumor at Study entry T2a | 12 participants | 15 participants | 3 participants |
| Diagnosis of Primary Tumor at Study entry T2b | 7 participants | 8 participants | 1 participants |
| Diagnosis of Primary Tumor at Study entry T2c | 7 participants | 14 participants | 7 participants |
| Diagnosis of Primary Tumor at Study entry T3 | 0 participants | 1 participants | 1 participants |
| Diagnosis of Primary Tumor at Study entry T3a | 1 participants | 1 participants | 0 participants |
| Diagnosis of Primary Tumor at Study entry TX | 0 participants | 1 participants | 1 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance status Grade 0 | 60 participants | 93 participants | 33 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance status Grade 1 | 4 participants | 8 participants | 4 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance status Missing | 1 participants | 2 participants | 1 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants | 97 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Initial diagnosis: Distant Metastasis (M) M0 | 56 participants | 90 participants | 34 participants |
| Initial diagnosis: Distant Metastasis (M) Not available | 9 participants | 13 participants | 4 participants |
| Initial diagnosis of Primary Tumor (T) Not available | 7 participants | 8 participants | 1 participants |
| Initial diagnosis of Primary Tumor (T) T1 | 2 participants | 5 participants | 3 participants |
| Initial diagnosis of Primary Tumor (T) T1a | 0 participants | 1 participants | 1 participants |
| Initial diagnosis of Primary Tumor (T) T1c | 24 participants | 40 participants | 16 participants |
| Initial diagnosis of Primary Tumor (T) T2 | 4 participants | 8 participants | 4 participants |
| Initial diagnosis of Primary Tumor (T) T2a | 13 participants | 15 participants | 2 participants |
| Initial diagnosis of Primary Tumor (T) T2b | 7 participants | 9 participants | 2 participants |
| Initial diagnosis of Primary Tumor (T) T2c | 8 participants | 15 participants | 7 participants |
| Initial diagnosis of Primary Tumor (T) T3 | 0 participants | 2 participants | 2 participants |
| Initial diagnosis: Regional Lymph Nodes (N) N0 | 41 participants | 59 participants | 18 participants |
| Initial diagnosis: Regional Lymph Nodes (N) Not available | 8 participants | 10 participants | 2 participants |
| Initial diagnosis: Regional Lymph Nodes (N) NX | 16 participants | 34 participants | 18 participants |
| Primary Gleason Score Primary grade 3 | 28 participants | 46 participants | 18 participants |
| Primary Gleason Score Primary grade 4 | 24 participants | 39 participants | 15 participants |
| Primary Gleason Score Primary grade missing | 13 participants | 18 participants | 5 participants |
| Prostate Cancer Type Adenocarcinoma insitu,Not otherwise specified(NOS) | 5 participants | 6 participants | 1 participants |
| Prostate Cancer Type Adenocarcinoma, NOS | 59 participants | 96 participants | 37 participants |
| Prostate Cancer Type Other | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Black or African American | 7 participants | 14 participants | 7 participants |
| Race/Ethnicity, Customized White | 58 participants | 89 participants | 31 participants |
| Secondary Gleason Score Secondary grade 3 | 22 participants | 34 participants | 12 participants |
| Secondary Gleason Score Secondary grade 4 | 28 participants | 47 participants | 19 participants |
| Secondary Gleason Score Secondary grade 5 | 2 participants | 4 participants | 2 participants |
| Secondary Gleason Score Secondary grade missing | 13 participants | 18 participants | 5 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 65 Participants | 103 Participants | 38 Participants |
| Study entry: M M0 | 51 participants | 79 participants | 28 participants |
| Study entry: M Not available | 14 participants | 24 participants | 10 participants |
| Study entry: N N0 | 39 participants | 58 participants | 19 participants |
| Study entry: N Not available | 13 participants | 22 participants | 9 participants |
| Study entry: N NX | 13 participants | 23 participants | 10 participants |
| Total Gleason Score Total Gleason score 6 | 5 participants | 7 participants | 2 participants |
| Total Gleason Score Total Gleason score 7 | 40 participants | 66 participants | 26 participants |
| Total Gleason Score Total Gleason score 8 | 5 participants | 8 participants | 3 participants |
| Total Gleason Score Total Gleason score 9 | 2 participants | 4 participants | 2 participants |
| Total Gleason Score Total Gleason score missing | 13 participants | 18 participants | 5 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 56 / 65 | 37 / 38 |
| serious Total, serious adverse events | 1 / 65 | 3 / 38 |
Outcome results
Primary
Percentage of Participants With Effective Castration Rate Over 25 Weeks
Castration rate is defined as the observed percentage of participants who have testosterone concentrations less than (\<) 50 nanogram per deciliter (ng/dL) (1.73 nanomole per liter \[nmol/L\]) at all scheduled visits.
Time frame: Day 1 Week 5 up to Day 1 Week 25
Population: Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: TAK-385 120 mg | Percentage of Participants With Effective Castration Rate Over 25 Weeks | 95 percentage of participants |
| Experimental: Degarelix 80 mg | Percentage of Participants With Effective Castration Rate Over 25 Weeks | 89 percentage of participants |
Secondary
Average Percent Change in Prostate Size
Percent change in prostate size was assessed at a follow up visit between Day 1 Week 9 to Day 1 Week 13.
Time frame: Baseline, Day 1 Week 9 to Day 1 Week 13
Population: Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: TAK-385 120 mg | Average Percent Change in Prostate Size | -25.1 percent change | Standard Deviation 20.03 |
| Experimental: Degarelix 80 mg | Average Percent Change in Prostate Size | -27.2 percent change | Standard Deviation 25.88 |
Secondary
Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score
EORTC QLQ-PR25 : EORTC module designed to supplement the QLQ-C30 for any application in prostate cancer. It Consist of 25 questions distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).
Time frame: Baseline and last post-baseline value up to Week 37
Population: Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: TAK-385 120 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | HTRS: Day 1 Week 5 | 6.55 units on scale | Standard Error 1.275 |
| Experimental: TAK-385 120 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | Sexual activity: Day 1 Week 29 | -19.06 units on scale | Standard Error 2.948 |
| Experimental: TAK-385 120 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | HTRS: Day 1 Week 13 | 10.06 units on scale | Standard Error 1.275 |
| Experimental: TAK-385 120 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | Sexual activity: Day 1 Week 13 | -17.43 units on scale | Standard Error 2.967 |
| Experimental: TAK-385 120 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | HTRS: Day 1 Week 25 | 13.34 units on scale | Standard Error 1.276 |
| Experimental: TAK-385 120 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | Sexual activity: Day 1 Week 33 | -12.40 units on scale | Standard Error 2.952 |
| Experimental: TAK-385 120 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | HTRS: Day 1 Week 29 | 11.53 units on scale | Standard Error 1.27 |
| Experimental: TAK-385 120 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | Sexual activity: Day 1 Week 5 | -9.78 units on scale | Standard Error 2.957 |
| Experimental: TAK-385 120 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | HTRS: Day 1 Week 33 | 9.62 units on scale | Standard Error 1.273 |
| Experimental: TAK-385 120 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | Sexual activity: Day 1 Week 37 | -6.60 units on scale | Standard Error 2.957 |
| Experimental: TAK-385 120 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | HTRS: Day 1 Week 37 | 8.67 units on scale | Standard Error 1.276 |
| Experimental: TAK-385 120 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | Sexual activity: Day 1 Week 25 | -19.32 units on scale | Standard Error 2.978 |
| Experimental: Degarelix 80 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | HTRS: Day 1 Week 37 | 11.31 units on scale | Standard Error 1.641 |
| Experimental: Degarelix 80 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | Sexual activity: Day 1 Week 5 | -9.53 units on scale | Standard Error 3.823 |
| Experimental: Degarelix 80 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | Sexual activity: Day 1 Week 13 | -11.54 units on scale | Standard Error 3.816 |
| Experimental: Degarelix 80 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | Sexual activity: Day 1 Week 29 | -5.12 units on scale | Standard Error 3.784 |
| Experimental: Degarelix 80 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | Sexual activity: Day 1 Week 33 | -9.94 units on scale | Standard Error 3.784 |
| Experimental: Degarelix 80 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | Sexual activity: Day 1 Week 37 | -6.00 units on scale | Standard Error 3.784 |
| Experimental: Degarelix 80 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | HTRS: Day 1 Week 5 | 7.02 units on scale | Standard Error 1.651 |
| Experimental: Degarelix 80 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | HTRS: Day 1 Week 13 | 9.98 units on scale | Standard Error 1.648 |
| Experimental: Degarelix 80 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | HTRS: Day 1 Week 25 | 12.48 units on scale | Standard Error 1.641 |
| Experimental: Degarelix 80 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | HTRS: Day 1 Week 29 | 10.43 units on scale | Standard Error 1.641 |
| Experimental: Degarelix 80 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | HTRS: Day 1 Week 33 | 10.72 units on scale | Standard Error 1.641 |
| Experimental: Degarelix 80 mg | Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score | Sexual activity: Day 1 Week 25 | -12.57 units on scale | Standard Error 3.784 |
Secondary
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score
EORTC QLQ-C30 included 30 questions comprising 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, nausea/vomiting), single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) and a global health and QOL scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'Very poor' to 7 'Excellent'). All domain scores were calculated as an average of item scores and transformed to 0-100 score range where a high score from 0-100 indicates: A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem.
Time frame: Baseline and last post-baseline value up to Week 37
Population: Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: TAK-385 120 mg | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score | Day 1 Week 5 | -5.10 units on scale | Standard Error 1.833 |
| Experimental: TAK-385 120 mg | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score | Day 1 Week 13 | -4.29 units on scale | Standard Error 1.837 |
| Experimental: TAK-385 120 mg | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score | Day 1 Week 25 | -10.04 units on scale | Standard Error 1.842 |
| Experimental: TAK-385 120 mg | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score | Day 1 Week 29 | -7.11 units on scale | Standard Error 1.826 |
| Experimental: TAK-385 120 mg | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score | Day 1 Week 33 | -6.24 units on scale | Standard Error 1.83 |
| Experimental: TAK-385 120 mg | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score | Day 1 Week 37 | -7.84 units on scale | Standard Error 1.833 |
| Experimental: Degarelix 80 mg | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score | Day 1 Week 33 | -6.39 units on scale | Standard Error 2.349 |
| Experimental: Degarelix 80 mg | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score | Day 1 Week 5 | -0.26 units on scale | Standard Error 2.37 |
| Experimental: Degarelix 80 mg | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score | Day 1 Week 29 | -8.14 units on scale | Standard Error 2.349 |
| Experimental: Degarelix 80 mg | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score | Day 1 Week 13 | -4.33 units on scale | Standard Error 2.364 |
| Experimental: Degarelix 80 mg | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score | Day 1 Week 37 | -6.61 units on scale | Standard Error 2.349 |
| Experimental: Degarelix 80 mg | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score | Day 1 Week 25 | -7.27 units on scale | Standard Error 2.349 |
Secondary
Estimated Time to Testosterone Recovery (TTR)
TTR is defined as the time from 1 day after the last dose of TAK-385 or 4 weeks plus 1 day after the last dose of degarelix to testosterone recovery. Testosterone recovery is defined as back to baseline or \>280 ng/dL whichever occurs first. TTR was determined during 12 weeks after the discontinuation of androgen deprivation therapy (ADT).
Time frame: Up to Day 1 Week 37
Population: Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental: TAK-385 120 mg | Estimated Time to Testosterone Recovery (TTR) | 91 days |
| Experimental: Degarelix 80 mg | Estimated Time to Testosterone Recovery (TTR) | 100 days |
Secondary
Number of Participants Reporting One or More TEAEs and Serious Adverse Events (SAEs)
Time frame: Baseline up to Week 29
Population: Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: TAK-385 120 mg | Number of Participants Reporting One or More TEAEs and Serious Adverse Events (SAEs) | TEAEs (including SAEs and non-SAEs) | 56 participants |
| Experimental: TAK-385 120 mg | Number of Participants Reporting One or More TEAEs and Serious Adverse Events (SAEs) | SAEs | 1 participants |
| Experimental: Degarelix 80 mg | Number of Participants Reporting One or More TEAEs and Serious Adverse Events (SAEs) | TEAEs (including SAEs and non-SAEs) | 37 participants |
| Experimental: Degarelix 80 mg | Number of Participants Reporting One or More TEAEs and Serious Adverse Events (SAEs) | SAEs | 3 participants |
Secondary
Number of Participants With PSA Response of >=50% and >=90% Reduction
Prostate-specific Antigen (PSA) response was defined as 50% and 90% reduction from baseline in serum PSA levels.
Time frame: Day 1 Week 13
Population: Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: TAK-385 120 mg | Number of Participants With PSA Response of >=50% and >=90% Reduction | >=50% reduction | 64 participants |
| Experimental: TAK-385 120 mg | Number of Participants With PSA Response of >=50% and >=90% Reduction | >=90% reduction | 36 participants |
| Experimental: Degarelix 80 mg | Number of Participants With PSA Response of >=50% and >=90% Reduction | >=50% reduction | 37 participants |
| Experimental: Degarelix 80 mg | Number of Participants With PSA Response of >=50% and >=90% Reduction | >=90% reduction | 18 participants |
Secondary
Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis
Time frame: Baseline up to Week 29
Population: Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: TAK-385 120 mg | Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis | Liver function analyses | 0 participants |
| Experimental: TAK-385 120 mg | Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis | Reproductive hormone analyses | 2 participants |
| Experimental: TAK-385 120 mg | Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis | Carbohydrate tolerance analyses inclusive diabetes | 1 participants |
| Experimental: TAK-385 120 mg | Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis | Cell marker analyses | 0 participants |
| Experimental: TAK-385 120 mg | Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis | Platelet analyses | 0 participants |
| Experimental: TAK-385 120 mg | Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis | Red blood cell analyses | 1 participants |
| Experimental: TAK-385 120 mg | Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis | Skeletal and cardiac muscle analyses | 1 participants |
| Experimental: TAK-385 120 mg | Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis | Urinalysis not elsewhere classified (NEC) | 1 participants |
| Experimental: Degarelix 80 mg | Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis | Urinalysis not elsewhere classified (NEC) | 0 participants |
| Experimental: Degarelix 80 mg | Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis | Liver function analyses | 6 participants |
| Experimental: Degarelix 80 mg | Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis | Platelet analyses | 1 participants |
| Experimental: Degarelix 80 mg | Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis | Reproductive hormone analyses | 4 participants |
| Experimental: Degarelix 80 mg | Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis | Skeletal and cardiac muscle analyses | 0 participants |
| Experimental: Degarelix 80 mg | Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis | Carbohydrate tolerance analyses inclusive diabetes | 0 participants |
| Experimental: Degarelix 80 mg | Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis | Red blood cell analyses | 0 participants |
| Experimental: Degarelix 80 mg | Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis | Cell marker analyses | 1 participants |
Secondary
Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings
Time frame: Baseline up to Week 29
Population: Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: TAK-385 120 mg | Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings | 1 participants |
| Experimental: Degarelix 80 mg | Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings | 1 participants |
Secondary
Number of Participants With TEAEs Related to Physical Findings
Time frame: Baseline up to Week 29
Population: Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: TAK-385 120 mg | Number of Participants With TEAEs Related to Physical Findings | 5 participants |
| Experimental: Degarelix 80 mg | Number of Participants With TEAEs Related to Physical Findings | 1 participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs
Time frame: Baseline up to Week 29
Population: Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: TAK-385 120 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs | 2 participants |
| Experimental: Degarelix 80 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs | 1 participants |
Secondary
Percentage of Participants Who Have Recovered to >280 ng/dL Testosterone
Time frame: Day 1 Week 25 up to Day 1 Week 37
Population: Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: TAK-385 120 mg | Percentage of Participants Who Have Recovered to >280 ng/dL Testosterone | 48 percentage of participants |
| Experimental: Degarelix 80 mg | Percentage of Participants Who Have Recovered to >280 ng/dL Testosterone | 13 percentage of participants |
Secondary
Percentage of Participants Who Have Recovered to Baseline Value of Testosterone
Time frame: Up to Day 1 Week 37
Population: Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: TAK-385 120 mg | Percentage of Participants Who Have Recovered to Baseline Value of Testosterone | 25 percentage of participants |
| Experimental: Degarelix 80 mg | Percentage of Participants Who Have Recovered to Baseline Value of Testosterone | 11 percentage of participants |
Secondary
Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score
AMS scale is a self-administered questionnaire used to 1) assess symptoms of aging (independent from those that are disease related) between groups of males under different conditions; 2) evaluate the severity of symptoms over time; and 3) measure changes before and after androgen therapy. Each question was answered between none (1) to extremely severe (5) for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total score is sum of all the item scores and range from 17 (minimum) to 85 (maximum), where high score indicated high level of symptoms.
Time frame: Day 1 of Weeks 5, 13, 25, 29, 33 and 37
Population: Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: TAK-385 120 mg | Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score | Day 1 Week 5 | 17.347 percent change | Standard Deviation 36.1328 |
| Experimental: TAK-385 120 mg | Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score | Day 1 Week 13 | 31.461 percent change | Standard Deviation 41.4029 |
| Experimental: TAK-385 120 mg | Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score | Day 1 Week 25 | 43.558 percent change | Standard Deviation 52.4934 |
| Experimental: TAK-385 120 mg | Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score | Day 1 Week 29 | 33.692 percent change | Standard Deviation 44.8331 |
| Experimental: TAK-385 120 mg | Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score | Day 1, Week 33 | 24.273 percent change | Standard Deviation 40.0869 |
| Experimental: TAK-385 120 mg | Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score | Day 1 Week 37 | 14.562 percent change | Standard Deviation 30.0487 |
| Experimental: Degarelix 80 mg | Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score | Day 1, Week 33 | 40.227 percent change | Standard Deviation 37.9232 |
| Experimental: Degarelix 80 mg | Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score | Day 1 Week 5 | 19.194 percent change | Standard Deviation 27.8573 |
| Experimental: Degarelix 80 mg | Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score | Day 1 Week 29 | 36.950 percent change | Standard Deviation 34.4352 |
| Experimental: Degarelix 80 mg | Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score | Day 1 Week 13 | 36.117 percent change | Standard Deviation 33.8115 |
| Experimental: Degarelix 80 mg | Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score | Day 1 Week 37 | 40.535 percent change | Standard Deviation 35.3799 |
| Experimental: Degarelix 80 mg | Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score | Day 1 Week 25 | 48.158 percent change | Standard Deviation 41.2365 |
Secondary
Percent Change From Baseline in Serum PSA Concentration
Time frame: Baseline, Day 1 of Week 2, 3 , 5, 9, 13, 17, 21, 25, 29, 33 and 37
Population: Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: TAK-385 120 mg | Percent Change From Baseline in Serum PSA Concentration | Day 1 Week 9 | -84.345 percent change | Standard Deviation 13.7231 |
| Experimental: TAK-385 120 mg | Percent Change From Baseline in Serum PSA Concentration | Day 1 Week 21 | -95.837 percent change | Standard Deviation 5.0062 |
| Experimental: TAK-385 120 mg | Percent Change From Baseline in Serum PSA Concentration | Day 1 Week 5 | -60.519 percent change | Standard Deviation 34.946 |
| Experimental: TAK-385 120 mg | Percent Change From Baseline in Serum PSA Concentration | Day 1 Week 25 | -97.430 percent change | Standard Deviation 3.365 |
| Experimental: TAK-385 120 mg | Percent Change From Baseline in Serum PSA Concentration | Day 1 Week 13 | -88.065 percent change | Standard Deviation 10.675 |
| Experimental: TAK-385 120 mg | Percent Change From Baseline in Serum PSA Concentration | Day 1 Week 29 | -96.614 percent change | Standard Deviation 4.7552 |
| Experimental: TAK-385 120 mg | Percent Change From Baseline in Serum PSA Concentration | Day 1 Week 3 | -35.798 percent change | Standard Deviation 48.5347 |
| Experimental: TAK-385 120 mg | Percent Change From Baseline in Serum PSA Concentration | Day 1 Week 33 | -94.697 percent change | Standard Deviation 6.4998 |
| Experimental: TAK-385 120 mg | Percent Change From Baseline in Serum PSA Concentration | Day 1 Week 17 | -90.433 percent change | Standard Deviation 10.0884 |
| Experimental: TAK-385 120 mg | Percent Change From Baseline in Serum PSA Concentration | Day 1 Week 37 | -94.998 percent change | Standard Deviation 5.6555 |
| Experimental: TAK-385 120 mg | Percent Change From Baseline in Serum PSA Concentration | Day 1 Week 2 | -29.348 percent change | Standard Deviation 21.9312 |
| Experimental: Degarelix 80 mg | Percent Change From Baseline in Serum PSA Concentration | Day 1 Week 37 | -97.144 percent change | Standard Deviation 6.6127 |
| Experimental: Degarelix 80 mg | Percent Change From Baseline in Serum PSA Concentration | Day 1 Week 2 | -26.756 percent change | Standard Deviation 36.9407 |
| Experimental: Degarelix 80 mg | Percent Change From Baseline in Serum PSA Concentration | Day 1 Week 3 | -14.292 percent change | Standard Deviation 108.1051 |
| Experimental: Degarelix 80 mg | Percent Change From Baseline in Serum PSA Concentration | Day 1 Week 5 | -64.509 percent change | Standard Deviation 32.5843 |
| Experimental: Degarelix 80 mg | Percent Change From Baseline in Serum PSA Concentration | Day 1 Week 9 | -78.364 percent change | Standard Deviation 42.6674 |
| Experimental: Degarelix 80 mg | Percent Change From Baseline in Serum PSA Concentration | Day 1 Week 13 | -85.735 percent change | Standard Deviation 14.9181 |
| Experimental: Degarelix 80 mg | Percent Change From Baseline in Serum PSA Concentration | Day 1 Week 17 | -87.712 percent change | Standard Deviation 13.8226 |
| Experimental: Degarelix 80 mg | Percent Change From Baseline in Serum PSA Concentration | Day 1 Week 21 | -94.347 percent change | Standard Deviation 9.4243 |
| Experimental: Degarelix 80 mg | Percent Change From Baseline in Serum PSA Concentration | Day 1 Week 25 | -96.268 percent change | Standard Deviation 7.6796 |
| Experimental: Degarelix 80 mg | Percent Change From Baseline in Serum PSA Concentration | Day 1 Week 29 | -96.858 percent change | Standard Deviation 7.5198 |
| Experimental: Degarelix 80 mg | Percent Change From Baseline in Serum PSA Concentration | Day 1 Week 33 | -97.309 percent change | Standard Deviation 7.321 |
Secondary
Plasma Concentrations of TAK-385
Time frame: Day 1 Week 1, 2, 3, 5, 9, 13, 17, 25, 33, 37: Pre-dose; Day 1 Week 5, 13: 2 hrs Post-dose; Day 4 Week 1: Pre-dose
Population: Safety population where TAK-385 assessments were available. Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: TAK-385 120 mg | Plasma Concentrations of TAK-385 | Day 1 Week 1: Predose | 0.1 nanogram per milliliter (ng/mL) | Standard Deviation 0.84 |
| Experimental: TAK-385 120 mg | Plasma Concentrations of TAK-385 | Day 1 Week 2: Predose | 11.9 nanogram per milliliter (ng/mL) | Standard Deviation 19.69 |
| Experimental: TAK-385 120 mg | Plasma Concentrations of TAK-385 | Day 1 Week 3: Predose | 10.4 nanogram per milliliter (ng/mL) | Standard Deviation 10.16 |
| Experimental: TAK-385 120 mg | Plasma Concentrations of TAK-385 | Day 1 Week 5: Predose | 9.3 nanogram per milliliter (ng/mL) | Standard Deviation 12.52 |
| Experimental: TAK-385 120 mg | Plasma Concentrations of TAK-385 | Day 1 Week 5: 2 hrs post-dose | 36.4 nanogram per milliliter (ng/mL) | Standard Deviation 38.14 |
| Experimental: TAK-385 120 mg | Plasma Concentrations of TAK-385 | Day 1 Week 9: Predose | 11.4 nanogram per milliliter (ng/mL) | Standard Deviation 18.48 |
| Experimental: TAK-385 120 mg | Plasma Concentrations of TAK-385 | Day 1 Week 13: Predose | 8.2 nanogram per milliliter (ng/mL) | Standard Deviation 6.25 |
| Experimental: TAK-385 120 mg | Plasma Concentrations of TAK-385 | Day 1 Week 13: 2 hrs post-dose | 35.8 nanogram per milliliter (ng/mL) | Standard Deviation 37.33 |
| Experimental: TAK-385 120 mg | Plasma Concentrations of TAK-385 | Day 1 Week 17: Predose | 8.7 nanogram per milliliter (ng/mL) | Standard Deviation 7.44 |
| Experimental: TAK-385 120 mg | Plasma Concentrations of TAK-385 | Day 1 Week 25: Predose | 9.5 nanogram per milliliter (ng/mL) | Standard Deviation 7.78 |
| Experimental: TAK-385 120 mg | Plasma Concentrations of TAK-385 | Day 1 Week 29: Predose | 0.3 nanogram per milliliter (ng/mL) | Standard Deviation 0.38 |
| Experimental: TAK-385 120 mg | Plasma Concentrations of TAK-385 | Day 1 Week 33: Predose | 0.1 nanogram per milliliter (ng/mL) | Standard Deviation 0.1 |
| Experimental: TAK-385 120 mg | Plasma Concentrations of TAK-385 | Day 1 Week 37: Predose | 0.1 nanogram per milliliter (ng/mL) | Standard Deviation 0.05 |
| Experimental: TAK-385 120 mg | Plasma Concentrations of TAK-385 | Day 4 Week 1: Predose | 10.5 nanogram per milliliter (ng/mL) | Standard Deviation 16.35 |
Secondary
PSA Nadir
Time frame: Baseline up to Day 1 Week 25
Population: Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: TAK-385 120 mg | PSA Nadir | 0.3 microgram per liter (mcg/L) | Standard Deviation 0.72 |
| Experimental: Degarelix 80 mg | PSA Nadir | 0.3 microgram per liter (mcg/L) | Standard Deviation 0.41 |
Secondary
Serum Follicle-Stimulating Hormone (FSH) Level
Time frame: Baseline, Day 1 of Week 2, 5, 13, 25 and 29
Population: Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: TAK-385 120 mg | Serum Follicle-Stimulating Hormone (FSH) Level | Baseline | 11.826 International units per liter (IU/L) | Standard Deviation 17.3909 |
| Experimental: TAK-385 120 mg | Serum Follicle-Stimulating Hormone (FSH) Level | Day 1 Week 2 | 2.363 International units per liter (IU/L) | Standard Deviation 2.9647 |
| Experimental: TAK-385 120 mg | Serum Follicle-Stimulating Hormone (FSH) Level | Day 1 Week 5 | 0.706 International units per liter (IU/L) | Standard Deviation 0.9289 |
| Experimental: TAK-385 120 mg | Serum Follicle-Stimulating Hormone (FSH) Level | Day 1 Week 13 | 0.849 International units per liter (IU/L) | Standard Deviation 1.1728 |
| Experimental: TAK-385 120 mg | Serum Follicle-Stimulating Hormone (FSH) Level | Day 1 Week 25 | 1.475 International units per liter (IU/L) | Standard Deviation 2.1842 |
| Experimental: TAK-385 120 mg | Serum Follicle-Stimulating Hormone (FSH) Level | Day 1 Week 29 | 7.427 International units per liter (IU/L) | Standard Deviation 5.4105 |
| Experimental: Degarelix 80 mg | Serum Follicle-Stimulating Hormone (FSH) Level | Day 1 Week 25 | 1.471 International units per liter (IU/L) | Standard Deviation 1.7437 |
| Experimental: Degarelix 80 mg | Serum Follicle-Stimulating Hormone (FSH) Level | Baseline | 11.716 International units per liter (IU/L) | Standard Deviation 14.7839 |
| Experimental: Degarelix 80 mg | Serum Follicle-Stimulating Hormone (FSH) Level | Day 1 Week 13 | 1.108 International units per liter (IU/L) | Standard Deviation 1.3469 |
| Experimental: Degarelix 80 mg | Serum Follicle-Stimulating Hormone (FSH) Level | Day 1 Week 2 | 2.519 International units per liter (IU/L) | Standard Deviation 2.818 |
| Experimental: Degarelix 80 mg | Serum Follicle-Stimulating Hormone (FSH) Level | Day 1 Week 29 | 2.032 International units per liter (IU/L) | Standard Deviation 1.9114 |
| Experimental: Degarelix 80 mg | Serum Follicle-Stimulating Hormone (FSH) Level | Day 1 Week 5 | 0.973 International units per liter (IU/L) | Standard Deviation 1.0951 |
Secondary
Serum Luteinizing Hormone (LH) Level
Time frame: Baseline, Day 1 of Weeks 2, 3, 5, 9, 13, 17, 21, 25, 29, and 37
Population: Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: TAK-385 120 mg | Serum Luteinizing Hormone (LH) Level | Day 1 Week 13 | 0.180 milli-international units per milliliter | Standard Deviation 0.3979 |
| Experimental: TAK-385 120 mg | Serum Luteinizing Hormone (LH) Level | Day 1 Week 2 | 0.388 milli-international units per milliliter | Standard Deviation 0.4167 |
| Experimental: TAK-385 120 mg | Serum Luteinizing Hormone (LH) Level | Day 1 Week 17 | 0.184 milli-international units per milliliter | Standard Deviation 0.369 |
| Experimental: TAK-385 120 mg | Serum Luteinizing Hormone (LH) Level | Day 1 Week 21 | 0.199 milli-international units per milliliter | Standard Deviation 0.467 |
| Experimental: TAK-385 120 mg | Serum Luteinizing Hormone (LH) Level | Day 1 Week 5 | 0.178 milli-international units per milliliter | Standard Deviation 0.2547 |
| Experimental: TAK-385 120 mg | Serum Luteinizing Hormone (LH) Level | Day 1 Week 25 | 0.325 milli-international units per milliliter | Standard Deviation 0.7243 |
| Experimental: TAK-385 120 mg | Serum Luteinizing Hormone (LH) Level | Baseline | 5.838 milli-international units per milliliter | Standard Deviation 5.0647 |
| Experimental: TAK-385 120 mg | Serum Luteinizing Hormone (LH) Level | Day 1 Week 29 | 4.204 milli-international units per milliliter | Standard Deviation 3.3259 |
| Experimental: TAK-385 120 mg | Serum Luteinizing Hormone (LH) Level | Day 1 Week 9 | 0.198 milli-international units per milliliter | Standard Deviation 0.4677 |
| Experimental: TAK-385 120 mg | Serum Luteinizing Hormone (LH) Level | Day 1 Week 37 | 9.441 milli-international units per milliliter | Standard Deviation 5.6144 |
| Experimental: TAK-385 120 mg | Serum Luteinizing Hormone (LH) Level | Day 1 Week 3 | 0.223 milli-international units per milliliter | Standard Deviation 0.382 |
| Experimental: Degarelix 80 mg | Serum Luteinizing Hormone (LH) Level | Day 1 Week 37 | 1.036 milli-international units per milliliter | Standard Deviation 1.4907 |
| Experimental: Degarelix 80 mg | Serum Luteinizing Hormone (LH) Level | Baseline | 6.943 milli-international units per milliliter | Standard Deviation 7.6683 |
| Experimental: Degarelix 80 mg | Serum Luteinizing Hormone (LH) Level | Day 1 Week 2 | 0.539 milli-international units per milliliter | Standard Deviation 0.7122 |
| Experimental: Degarelix 80 mg | Serum Luteinizing Hormone (LH) Level | Day 1 Week 3 | 0.362 milli-international units per milliliter | Standard Deviation 0.5648 |
| Experimental: Degarelix 80 mg | Serum Luteinizing Hormone (LH) Level | Day 1 Week 5 | 0.252 milli-international units per milliliter | Standard Deviation 0.328 |
| Experimental: Degarelix 80 mg | Serum Luteinizing Hormone (LH) Level | Day 1 Week 9 | 0.333 milli-international units per milliliter | Standard Deviation 0.5649 |
| Experimental: Degarelix 80 mg | Serum Luteinizing Hormone (LH) Level | Day 1 Week 13 | 0.265 milli-international units per milliliter | Standard Deviation 0.5073 |
| Experimental: Degarelix 80 mg | Serum Luteinizing Hormone (LH) Level | Day 1 Week 21 | 0.294 milli-international units per milliliter | Standard Deviation 0.5523 |
| Experimental: Degarelix 80 mg | Serum Luteinizing Hormone (LH) Level | Day 1 Week 25 | 0.342 milli-international units per milliliter | Standard Deviation 0.6248 |
| Experimental: Degarelix 80 mg | Serum Luteinizing Hormone (LH) Level | Day 1 Week 29 | 0.464 milli-international units per milliliter | Standard Deviation 0.5756 |
| Experimental: Degarelix 80 mg | Serum Luteinizing Hormone (LH) Level | Day 1 Week 17 | 0.283 milli-international units per milliliter | Standard Deviation 0.5461 |
Secondary
Serum PSA Concentration
Time frame: Day 1 of Week 13, 25, 29, 33 and 37
Population: Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: TAK-385 120 mg | Serum PSA Concentration | Day 1 Week 13 | 1.104 mcg/L | Standard Deviation 1.3287 |
| Experimental: TAK-385 120 mg | Serum PSA Concentration | Day 1 Week 29 | 0.268 mcg/L | Standard Deviation 0.3357 |
| Experimental: TAK-385 120 mg | Serum PSA Concentration | Day 1 Week 25 | 0.223 mcg/L | Standard Deviation 0.3343 |
| Experimental: TAK-385 120 mg | Serum PSA Concentration | Day 1 Week 33 | 0.431 mcg/L | Standard Deviation 0.5455 |
| Experimental: TAK-385 120 mg | Serum PSA Concentration | Day 1 Week 37 | 0.410 mcg/L | Standard Deviation 0.4635 |
| Experimental: Degarelix 80 mg | Serum PSA Concentration | Day 1 Week 33 | 0.183 mcg/L | Standard Deviation 0.3503 |
| Experimental: Degarelix 80 mg | Serum PSA Concentration | Day 1 Week 37 | 0.210 mcg/L | Standard Deviation 0.3325 |
| Experimental: Degarelix 80 mg | Serum PSA Concentration | Day 1 Week 13 | 1.486 mcg/L | Standard Deviation 2.1381 |
| Experimental: Degarelix 80 mg | Serum PSA Concentration | Day 1 Week 25 | 0.274 mcg/L | Standard Deviation 0.4448 |
| Experimental: Degarelix 80 mg | Serum PSA Concentration | Day 1 Week 29 | 0.211 mcg/L | Standard Deviation 0.3653 |
Secondary
Serum Sex Hormone-Binding Globulin (SHBG) Level
Time frame: Baseline, Day 1 of Week 2, 5, 13, 25 and 29
Population: Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: TAK-385 120 mg | Serum Sex Hormone-Binding Globulin (SHBG) Level | Baseline | 45.528 nmol/L | Standard Deviation 21.3167 |
| Experimental: TAK-385 120 mg | Serum Sex Hormone-Binding Globulin (SHBG) Level | Day 1 Week 2 | 49.474 nmol/L | Standard Deviation 22.3975 |
| Experimental: TAK-385 120 mg | Serum Sex Hormone-Binding Globulin (SHBG) Level | Day 1 Week 5 | 46.797 nmol/L | Standard Deviation 22.6572 |
| Experimental: TAK-385 120 mg | Serum Sex Hormone-Binding Globulin (SHBG) Level | Day 1 Week 13 | 46.083 nmol/L | Standard Deviation 24.6853 |
| Experimental: TAK-385 120 mg | Serum Sex Hormone-Binding Globulin (SHBG) Level | Day 1 Week 25 | 46.258 nmol/L | Standard Deviation 25.0679 |
| Experimental: TAK-385 120 mg | Serum Sex Hormone-Binding Globulin (SHBG) Level | Day 1 Week 29 | 43.329 nmol/L | Standard Deviation 20.8 |
| Experimental: Degarelix 80 mg | Serum Sex Hormone-Binding Globulin (SHBG) Level | Day 1 Week 25 | 44.305 nmol/L | Standard Deviation 22.2005 |
| Experimental: Degarelix 80 mg | Serum Sex Hormone-Binding Globulin (SHBG) Level | Baseline | 41.784 nmol/L | Standard Deviation 17.8412 |
| Experimental: Degarelix 80 mg | Serum Sex Hormone-Binding Globulin (SHBG) Level | Day 1 Week 13 | 42.992 nmol/L | Standard Deviation 19.2416 |
| Experimental: Degarelix 80 mg | Serum Sex Hormone-Binding Globulin (SHBG) Level | Day 1 Week 2 | 43.386 nmol/L | Standard Deviation 15.9911 |
| Experimental: Degarelix 80 mg | Serum Sex Hormone-Binding Globulin (SHBG) Level | Day 1 Week 29 | 42.739 nmol/L | Standard Deviation 21.911 |
| Experimental: Degarelix 80 mg | Serum Sex Hormone-Binding Globulin (SHBG) Level | Day 1 Week 5 | 41.778 nmol/L | Standard Deviation 15.7575 |
Secondary
Time to Achieve Effective Castration
Time to effective castration is defined as days from first dose to first testosterone measurement that is \<50 ng/dL.
Time frame: Baseline up to Week 37
Population: Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental: TAK-385 120 mg | Time to Achieve Effective Castration | 4 days |
| Experimental: Degarelix 80 mg | Time to Achieve Effective Castration | 3 days |
Secondary
Time to Achieve Profound Castration
Time to profound castration is defined as days from first dose to first testosterone measurement that is \<20 ng/dL.
Time frame: Baseline up to Week 37
Population: Safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental: TAK-385 120 mg | Time to Achieve Profound Castration | 15 days |
| Experimental: Degarelix 80 mg | Time to Achieve Profound Castration | 12 days |