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

Androgens

Androgen Antagonists

Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth. Study drug treatment continued until disease progression, unacceptable toxicity, or withdrawal.

Enzalutamide

Pfizer CT.gov Call Center

Medical Monitor

This study is being conducted to determine the effect of enzalutamide on the androgen signaling pathway in correlation with the anti-tumor effects of enzalutamide to identify potential predictors of response or resistance to therapy.

Determine Effect of Enzalutamide (MDV3100) on the Androgen Signaling Pathway in Correlation With the Anti-tumor Effects of Enzalutamide

A Study Of Continuous Oral Dosing Of A Novel Antiandrogen Mdv3100, In Castration-resistant Bone Metastatic Prostate Cancer Patients Evaluating The Tumor Micro-enviroment

Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit.

Assessment of intratumoral testosterone was assessed by liquid chromatography mass spectrometry.

Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit.

Assessment of intratumoral dihydrotestosterone was assessed by liquid chromatography mass spectrometry.

Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral testosterone was assessed by liquid chromatography mass spectrometry.

Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.

The change from baseline in bone marrow testosterone levels at Week 9 was correlated with PSA response status at Week 9.

Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral dihydrotestosterone was assessed by liquid chromatography mass spectrometry.

Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.

The change from baseline in bone marrow dihydrotestosterone levels at Week 9 was correlated with PSA response status at Week 9.

Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.

Exposure to study drug through the data cutoff of 26AUG2011 only. Fifteen participants (25.0%) were still on study drug as of the data cut-off date and were censored at this date.

Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 5.

Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 9.

Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 17.

Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 25.

Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 41.

Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 49.

Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 57.

Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 65.

Astellas Pharma Inc

Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

Pfizer

Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.

Age, Continuous

< 55

55 to < 65

65 to < 75

>= 75

Age, Customized

Sex: Female, Male

Mohammad Hirmand, MD, VP, Clinical Development

Participants who received any amount of enzalutamide and had bone marrow testosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required.

Change From Baseline in Bone Marrow Testosterone

>=50% Reduction in PSA from Baseline

>=90% Reduction in PSA from Baseline

Participants who received any amount of enzalutamide and had PSA values at baseline and at the Week 9 Visit.

Percentage of Participants at Week 9 With a Response in Prostate-Specific Antigen (PSA)

Participants who received any amount of enzalutamide and had bone marrow dihydrotestosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required.

Change From Baseline in Bone Marrow Dihydrotestosterone

PSA responders are defined by a greater than or equal to 50% reduction from baseline in PSA at Week 9

Enzalutamide, PSA Responders at Week 9

PSA non-responders are defined by a less than 50% reduction from baseline in PSA at Week 9

Enzalutamide, PSA Non-Responders at Week 9

Change From Baseline in Bone Marrow Testosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status

Change From Baseline in Bone Marrow Dihydrotestosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status

All participants who received any amount of enzalutamide. Fifteen (25.0%) participants were still on study drug as of the data cutoff date and were censored at the data cutoff date.

Median Time to Study Drug Discontinuation

Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 5.

Change From Baseline in Urinary N-Telopeptide

Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 9.

Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 17.

Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 25.

Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 33.

Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 41.

Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 49.

Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 57.

Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 65.

Spots Global Cancer Trial Database for Determine Effect of Enzalutamide (MDV3100) on the Androgen Signaling Pathway in Correlation With the Anti-tumor Effects of Enzalutamide

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