Percentage of Participants With Effective Castration Rate Over 25 Weeks
| Group | Value (percentage of participants) |
|---|---|
| Experimental: TAK-385 120 mg | 95 |
| Experimental: Degarelix 80 mg | 89 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States, United Kingdom
1 trial · 1 completed · 1 with posted results
Safety and Efficacy of TAK-385 for Patients With Localized Prostate Cancer
NCT02135445Jun 2014 to Dec 2015
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to evaluate the efficacy of TAK-385 for achieving and maintaining testosterone suppression.
Experimental
TAK-385
TAK-385 320 mg, tablets, orally, once, on Day 1, followed by TAK-385 120 mg, orally, once daily for 24 weeks. Each participant may have one upward dose adjustment of 40 mg for efficacy and/or one downward dose adjustment of 40 mg for safety during the study.
Active comparator
Degarelix
Degarelix 240 mg, injection, subcutaneous, on Day 1, followed by degarelix 80 mg, injection, subcutaneous, once every four weeks, for 24 weeks.
Outcomes the sponsor listed as primary.
Percentage of Participants With Effective Castration Rate Over 25 Weeks
Time frame · 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.
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
Time frame · 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
Time frame · 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
Time frame · 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)
Time frame · 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
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
Time frame · Day 1 Week 13
Prostate-specific Antigen (PSA) response was defined as 50% and 90% reduction from baseline in serum PSA levels.
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
Time frame · 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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of participants) |
|---|---|
| Experimental: TAK-385 120 mg | 95 |
| Experimental: Degarelix 80 mg | 89 |
| Group | Value (participants) |
|---|---|
| Experimental: TAK-385 120 mg | 2 |
| Experimental: Degarelix 80 mg | 1 |
| Group | Value (participants) |
|---|---|
| Experimental: TAK-385 120 mg | 5 |
| Experimental: Degarelix 80 mg | 1 |
| Group | Value (participants) |
|---|---|
| Experimental: TAK-385 120 mg | 1 |
| Experimental: Degarelix 80 mg | 1 |
| Group | Value (participants) |
|---|---|
| Experimental: TAK-385 120 mg | 0 |
| Experimental: Degarelix 80 mg | 6 |
| Group | Value (participants) |
|---|---|
| Experimental: TAK-385 120 mg | 56 |
| Experimental: Degarelix 80 mg | 37 |
| Group | Value (percent change) | Spread |
|---|---|---|
| Experimental: TAK-385 120 mg | -25.1 | 20.03 |
| Experimental: Degarelix 80 mg | -27.2 | 25.88 |
| Group | Value (days) |
|---|---|
| Experimental: TAK-385 120 mg | 4 |
| Experimental: Degarelix 80 mg | 3 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Experimental: TAK-385 120 mgTAK-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. | – | 1 / 65 | 56 / 65 |
| Experimental: Degarelix 80 mgDegarelix 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. | – | 3 / 38 | 37 / 38 |
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