The purpose of this study is to evaluate the efficacy of TAK-385 for achieving and maintaining testosterone suppression.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
103
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
San Diego, California, United States
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
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs
Time frame: Baseline up to Week 29
Number of Participants With TEAEs Related to Physical Findings
Time frame: Baseline up to Week 29
Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings
Time frame: Baseline up to Week 29
Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis
Time frame: Baseline up to Week 29
Number of Participants Reporting One or More TEAEs and Serious Adverse Events (SAEs)
Time frame: Baseline up to Week 29
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
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
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Unnamed facility
Denver, Colorado, United States
Unnamed facility
Bradenton, Florida, United States
Unnamed facility
Daytona Beach, Florida, United States
Unnamed facility
Fort Lauderdale, Florida, United States
Unnamed facility
Fort Myers, Florida, United States
Unnamed facility
Plantation, Florida, United States
Unnamed facility
Jeffersonville, Indiana, United States
Unnamed facility
Wichita, Kansas, United States
...and 15 more locations
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
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
Percentage of Participants Who Have Recovered to Baseline Value of Testosterone
Time frame: Up to Day 1 Week 37
Percentage of Participants Who Have Recovered to >280 ng/dL Testosterone
Time frame: Day 1 Week 25 up to Day 1 Week 37
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
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
PSA Nadir
Time frame: Baseline up to Day 1 Week 25
Serum PSA Concentration
Time frame: Day 1 of Week 13, 25, 29, 33 and 37
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
Serum Luteinizing Hormone (LH) Level
Time frame: Baseline, Day 1 of Weeks 2, 3, 5, 9, 13, 17, 21, 25, 29, and 37
Serum Follicle-Stimulating Hormone (FSH) Level
Time frame: Baseline, Day 1 of Week 2, 5, 13, 25 and 29
Serum Sex Hormone-Binding Globulin (SHBG) Level
Time frame: Baseline, Day 1 of Week 2, 5, 13, 25 and 29
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
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
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