Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Hormones

Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.

Enzalutamide

Use Central Contact

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

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

A Phase 2, Open-label, Single-arm, Efficacy and Safety Study of Enzalutamide (MDV3100) in Patients With Hormone-naïve Prostate Cancer

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.

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.

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.

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.

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.

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 or 169 were considered non-responders.

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 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 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 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 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 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.

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.

Medivation, Inc.

Astellas Pharma Inc

Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.

Age, Continuous

Sex: Female, Male

Body Mass Index (BMI)

Prostate Specific Antigen (PSA)

Duration of Prostate Cancer

Unknown

A system of grading prostate cancer tissue based on how it looks under a microscope. Gleason scores range from 2 to 10 and indicate how likely it is that a tumor will spread. A low Gleason score means the cancer tissue is similar to normal prostate tissue and the tumor is less likely to spread; a high Gleason score means the cancer tissue is very different from normal and the tumor is more likely to spread.

Total Gleason Score at Initial Diagnosis

TX: Primary tumor cannot be assessed

T0: No evidence of primary tumor

T1: Tumor neither palpable or visible by imaging

T2: Tumor confined within the prostate

T3: Tumor extends through the prostatic capsule

T4: Tumor is fixed or invades adjacent structures

Clinical Tumor Stage (T) at Initial Diagnosis

NX: Regional lymph nodes were not assessed

N0: No regional lymph node metastasis

N1: Metastasis in regional lymph node(s)

Clinical Lymph Node Stage (N) at Initial Diagnosis

MX: Distant metastasis could not be assessed

M0: No distant metastasis

M1: Distant metastasis

Distant Metastasis (M) at Initial Diagnosis

Participants With Metastases at Study Entry

Number of Metastatic Lesions by Bone Scan

Radiotherapy

Prostatectomy

Transurethral Resection of the Prostate

Pelvic Lymph Node Dissection

Watchful Waiting

Other Surgeries/Procedures

Participants may have received more than one intervention

Previous Interventions

Clinical Trial Disclosure

The analysis population was safety analysis set (SAF), which consisted of participants who received at least one dose of study drug.

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

Any Adverse Events

Drug Regimen Related Adverse Events

Deaths

Serious Adverse Events

Drug Regimen Related Serious Adverse Events

AEs Leading to Discontinuation of Study Drug

DRRAEs Leading to Discontinuation of Study Drug

Number of Participants With Adverse Events

Week 25

Week 49

Week 97

Week 169

Week 265 (End of Study)

Safety Analysis Set with available data at each time point

Percent Change From Baseline in PSA

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

Percent Change From Baseline in Androstenedione

Percent Change From Baseline in Dehydroepiandrosterone (DHEA)

Percent Change From Baseline in Dihydrotestosterone (DHT)

Percent Change From Baseline in Estradiol

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

Percent Change From Baseline in Luteinizing Hormone (LH)

Percent Change From Baseline in Prolactin

Percent Change From Baseline in Total Testosterone

Percent Change From Baseline in Free Testosterone

Week 2

Week 3

Week 4

Week 5

Week 9

Week 13

Week 21

Pharmacokinetic Analysis Set (PKAS) (participants who had taken at least 1 dose of study drug and who had at least 1 pharmacokinetic concentration value) with available data at each time point

Plasma Concentration of Enzalutamide at Pre-dose (Ctrough)

Pharmacokinetic Analysis Set with available data at each time point

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

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

Safety Analysis Set; Week 49, 97 and 169 analyses include participants who were on study at each time point

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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