A Study to Test if Enzalutamide is Effective and Safe in Prostate Cancer Patients Who Have Never Had Hormone Therapy

Phase 2CompletedNCT01302041

Astellas Pharma Inc67 enrolled

Overview

To evaluate the effect of enzalutamide on prostate specific antigen (PSA) level in men with prostate cancer.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

EnzalutamideDRUG

Oral

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant therapy) * Asymptomatic from prostate cancer * Non-castrate level of testosterone (≥ 8 nmol/L (230 ng/dL)) at screening * PSA ≥ 2 ng/mL at screening Exclusion Criteria: Has previously or is currently receiving: * Hormonal therapy with intent to treat prostate cancer * Systemic glucocorticoids * Chemotherapy with the intent to treat prostate cancer * Opiate analgesics for pain from prostate cancer * Radiation therapy for treatment of the primary tumor or metastases * Has history of known or suspected brain or skull metastases or leptomeningeal disease * Has history of seizure including febrile seizure or any condition that may predispose to seizure or history of loss of consciousness or transient ischemic attack * Clinically significant cardiovascular disease

Locations (12)

Site BE1003

Brussels, Belgium

Site BE1001

Brussels, Belgium

Site BE1002

Kortrijk, Belgium

Site BE1005

Leuven, Belgium

Outcomes

Primary Outcomes

Percentage of Participants With a Prostate-Specific Antigen (PSA) Response at Week 25

A PSA response was defined as a decline from Baseline in PSA level of 80% or greater. Blood samples for PSA were collected and analyzed at a central laboratory. Participants with an unknown or missing response or who discontinued prior to week 25 for any reason were treated as non-responders.

Time frame: Baseline and Week 25

Secondary Outcomes

Number of Participants With Adverse Events

Each adverse event (AE) was assessed by the investigator for causal relationship to the study drug; those deemed possibly or probably related to study drug are reported as drug regimen related AEs (DRRAEs). A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose: * Resulted in death * Was life-threatening * Resulted in persistent or significant disability/incapacity * Resulted in congenital anomaly or birth defect * Required inpatient hospitalization or led to prolongation of hospitalization * Other medically important events.

Time frame: From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)

Percent Change From Baseline in PSA

Time frame: Baseline and Weeks 25, 49, 97, 169 and Week 265 (End of Study)

Percent Change From Baseline in Sex Hormone-Binding Globulin (SHBG)

Time frame: Baseline and Weeks 25 and 49

Percent Change From Baseline in Androstenedione

Time frame: Baseline and Weeks 25 and 49

Percent Change From Baseline in Dehydroepiandrosterone (DHEA)

Time frame: Baseline and Weeks 25 and 49

Percent Change From Baseline in Dihydrotestosterone (DHT)

Data from ClinicalTrials.gov

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Site CZ3006

Olomouc, Czechia

Site CZ3002

Prague, Czechia

Site DK4001

Aarhus N, Denmark

Site DK4004

Copenhagen, Denmark

Site DK4002

Herlev, Denmark

Site DE5005

Aachen, Germany

...and 2 more locations

Time frame: Baseline and Week 25 and 49

Percent Change From Baseline in Estradiol

Time frame: Baseline and Weeks 25 and 49

Percent Change From Baseline in Follicle-Stimulating Hormone (FSH)

Time frame: Baseline and Weeks 25 and 49

Percent Change From Baseline in Luteinizing Hormone (LH)

Time frame: Baseline and Weeks 25 and 49

Percent Change From Baseline in Prolactin

Time frame: Baseline and Weeks 25 and 49

Percent Change From Baseline in Total Testosterone

Time frame: Baseline and Weeks 25 and 49

Percent Change From Baseline in Free Testosterone

Time frame: Baseline and Weeks 25 and 49

Plasma Concentration of Enzalutamide at Pre-dose (Ctrough)

Time frame: Pre-dose at Weeks 2, 3, 4, 5, 9, 13, 21 and 25

Plasma Concentration of Enzalutamide Metabolite M2 at Pre-dose (Ctrough)

Time frame: Pre-dose at Weeks 2, 3, 4, 5, 9, 13, 21 and 25

Percentage of Participants With a PSA Response at Weeks 49, 97 and 169

A PSA response was defined as a decline from baseline in PSA level of 80% or greater. Blood samples for PSA were collected and analyzed at a central laboratory. Participants with an unknown or missing response or who discontinued prior to week 49, week 97 or week 169 for any reason were treated as non-responders.

Time frame: Baseline and Weeks 49, 97 and 169

Percentage of Participants With a 90% or Greater Reduction From Baseline in PSA Level

Participants with unknown or missing PSA results at week 25 or who discontinued prior to week 25 were considered non-responders at week 25. Participants with unknown or missing PSA results at week 49, week 97 or week 169 were considered non-responders.

Time frame: Baseline and Weeks 25, 49, 97 and 169

Percentage of Participants With PSA ≤ 4 ng/ml

Participants with unknown or missing PSA results at week 25 or who discontinued prior to Week 25 were considered non-responders at Week 25. Participants with unknown or missing PSA results at week 49, 97 and 169 were considered non-responders.

Time frame: Weeks 25, 49, 97 and 169

Percentage of Participants With PSA ≤ 0.1 ng/ml

Time frame: Weeks 25, 49, 97 and 169

Maximum Decline From Baseline in PSA

The maximum decline from Baseline in PSA was calculated as the largest reduction from Baseline in PSA level that occurred at any point after treatment start up to week 25 and up to and including the assessment made at the safety follow-up visit, divided by the PSA Baseline value and multiplied by 100, i.e., the maximum percent change from baseline.

Time frame: Baseline to Week 25 and from Baseline up to the EOS date of 27 Apr 2017; median duration of treatment of 1666.0 days (range of 52-2052)

Time to PSA Response

Time to PSA response (PSA decline ≥ 80% from Baseline) is defined as the time interval from the first study drug dose to the first date a decline from Baseline in PSA level of 80% or greater was recorded. Time to response was estimated using the Kaplan-Meier method.

Time frame: From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)

Time to PSA Decline ≥ 90%

Time to PSA decline ≥ 90% is defined as the time interval from the first study drug dose to the first date a decline from Baseline in PSA level of 90% or greater was recorded. Time to PSA decline ≥ 90% was estimated using the Kaplan-Meier method.

Time frame: From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)

Time to PSA ≤ 4 ng/ml

Time to PSA ≤ 4 ng/ml is defined as the time interval from the first study drug dose to the first date a decline in PSA to a result of 4 ng/ml or below was recorded. Time to PSA ≤ 4 ng/ml was estimated using the Kaplan-Meier method.

Time frame: From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)

Time to PSA ≤ 0.1 ng/ml

Time to PSA ≤ 0.1 ng/ml is defined as the time interval from the first study drug dose to the first date a decline in PSA to a result of 0.1 ng/ml or below was recorded. Time to PSA ≤ 0.1 ng/ml was estimated using the Kaplan-Meier method.

Time frame: From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)

Time to PSA Progression

Time to PSA progression is defined as the time interval from the first study drug dose to the first date of PSA progression. PSA progression is defined as a ≥ 25% increase in PSA with an absolute increase of ≥ 2 ng/mL above the nadir unless the PSA next measurement(s), if available, does not confirm the PSA progression.

Time frame: From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)

PSA Doubling Time

PSA doubling time was to be calculated from the slope estimated from a linear regression of the natural log of PSA fitted on time, if the slope was positive. Since the slope was negative for all participants, PSA doubling time could not be calculated.

Time frame: From Baseline to Week 25