Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Kennedy Disease

All Drugs and Chemicals

Androgens

Participants received 160 mg enzalutamide orally once a day. Participants continued on treatment unless the dose was reduced or treatment was interrupted during the study.

Enzalutamide

Clinical Study Manager

A study to assess the safety of continued administration of MDV3100 in subjects with Prostate Cancer who have already undergone treatment with MDV3100 and showed benefit.

This was a multi-center extension study in participants with prostate cancer who have completed MDV3100 treatment study to assess the long-term safety of continued administration of MDV3100, when judged by the investigator to be in the best interest of the participant. For the study duration, all participants with castration-resistant prostate cancer (CRPC) maintained androgen deprivation with a Luteinizing Hormone Releasing Hormone (LHRH) agonist/antagonist unless they underwent bilateral orchiectomy. Participants were discontinued from study drug when the continued administration of study drug was deemed to be not in the participants' best interest by the investigator based on clinical assessment. Throughout the study, safety and tolerability were assessed by the recording of adverse events, monitoring of vital signs and physical examinations, safety laboratory evaluations, and 12-lead electrocardiograms (ECGs). Participants had a safety follow-up visit 30 days after their last dose of study drug. Participants that did not meet any of the discontinuation criteria were eligible to continue to receive treatment with enzalutamide in study 9785-CL-0123 \[NCT02960022\] upon approval and activation of the study at the participating institution. Participants who enrolled in study 9785-CL-0123 \[NCT02960022\] were not required to have a safety follow-up visit.

A Study to Assess the Safety of Continued Administration of MDV3100 in Subjects With Prostate Cancer Who Showed Benefit From Prior Exposure to MDV3100

A Phase 2 Open-label Extension Study to Assess the Safety of Continued Administration of MDV3100 in Subjects With Prostate Cancer Who Showed Benefit From Prior Exposure to MDV3100

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

An AE was defined as any untoward medical occurrence in a participant administered study drug or who underwent study procedures and did not necessarily have a causal relationship with treatment. An abnormality identified during a medical test was defined as an AE only if the abnormality induced clinical signs or symptoms, required active intervention, required interruption, or discontinuation of study medication, or was clinically significant in the opinion of the investigator. An AE was defined as serious if it resulted in any of the following outcomes: Death, Was life-threatening, Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, Congenital anomaly, or birth defect, Inpatient hospitalization or prolongation of hospitalization, Other medically important event. Drug-related AEs were those assessed by the investigator as AEs whose relationship to the to the study drugs could not be ruled out.

Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

Astellas Pharma Inc

The total number of deaths (all causes) includes deaths reported after the time frame above.

Enzalutimide

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The duration of prostate cancer was calculated as (Date of first enzalutamide intake in the parent study - Date of initial diagnosis) + 1.

Duration of Prostate Cancer

Score 3

Score 4

Score 5

Unknown

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

Primary Gleason Score at Initial Diagnosis

Secondary Gleason Score at Initial Diagnosis

Score 6

Score 7

Score 8

Score 9

Total Gleason Score at Initial Diagnosis

TX - Primary Tumor Cannot be Assessed

T0 - No Evidence of Primary Tumor

T1 - Clinically Tumor Not Palpable or Visible

T2 - Tumor Confined Within the Prostate

T3 - Tumor Extends Through the Prostatic Capsule

T4 - Tumor Fixed or Invades Adjacent Structures

Primary Tumor Assessment at Initial Diagnosis - Clinical Tumor Stage (T)

pT2 - Organ Confined

pT3 - Extraprostatic Extension

pT4 - Invasion of Bladder, Rectum

Pathologic Tumor Stage (pT)

NX - Regional Lymph Nodes Were Not Assessed

N0 - No Regional Lymph Node Metastasis

N1 - Metastasis in Regional Lymph Node(s)

pNX - Regional Lymph Nodes Not Sampled

pN0 - No Positive Regional Nodes

pN1 - Metastasis in Regional Nodes(s)

Regional Lymph Nodes (N) at Initial Diagnosis

MX - Distant Metastasis Cannot be Assessed

M0 - No Distant Metastasis

M1 - Distant Metastasis

Distant Metastasis at Initial Diagnosis

<= 60

> 60 - <182

>= 182 - <365

>= 365

Treatment duration in the extension study was calculated as (Date of last dose of MDV3100 - Date of first dose of MDV3100 in the extension study)+ 1.

Treatment Duration in Extension Study

The analysis population was the Safety Analysis Set (SAF), which consisted of participants who received at least one dose of enzalutamide during the extension study. This extension study's baseline was considered the original baseline from the prior parent studies with enzalutamide.

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