Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer

NCT ID: NCT02918968

Last Updated: 2024-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-02
• Study Completion Date: 2020-03-27

Brief Summary

The objective of this study was to compare the efficacy and safety of the combination therapy with enzalutamide + androgen deprivation therapy (ADT) and the combination therapy with flutamide + ADT in patients with castration resistant prostate cancer who had relapsed during combined androgen blockade (CAB) therapy with bicalutamide and ADT. This study also investigated the order of alternative antiandrogen therapy (AAT) by changing the 1st line medication after relapse of prostate-specific antigen (PSA).

Conditions

Prostate Cancer

Keywords

enzalutamide; Xtandi; Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enzalutamide 160 mg 1st line AAT/Flutamide 375 mg 2nd line AAT

Participants received enzalutamide 160 mg capsules, orally once daily as 1st line of alternative antiandrogen therapy (AAT) until confirmed prostate-specific antigen (PSA) progression, other disease progression, or an intolerable adverse event. After confirmation of PSA progression, other disease progression, or an intolerable adverse event, participants received flutamide 125 mg tablets orally thrice daily after each meal as 2nd line of AAT. Treatment with each drug was continued until the participant met any of the discontinuation criteria or until 2 years from the enrollment of the last participant (approximately 38 months).

Group Type: EXPERIMENTAL

Enzalutamide

Intervention Type: DRUG

Oral Capsule

Flutamide

Intervention Type: DRUG

Oral tablet

Androgen deprivation therapy

Intervention Type: OTHER

All subjects must undergo continuous Androgen deprivation therapy with GnRH agonist/antagonist or bilateral orchiectomy during the study period.

Flutamide 375 mg 1st line AAT/Enzaltumide 160 mg 2nd line AAT

Participants received flutamide 125 mg tablets orally thrice daily after each meal as 1st line of AAT until confirmed PSA progression, other disease progression, or an intolerable adverse event. After confirmed PSA progression, other disease progression, or an intolerable adverse event. participants received enzalutamide 160 mg capsules orally once daily as 2nd line of AAT. Treatment with each drug was continued until the participant met any of the discontinuation criteria or until 2 years from the enrollment of the last participant (approximately 38 months).

Group Type: EXPERIMENTAL

Enzalutamide

Intervention Type: DRUG

Oral Capsule

Flutamide

Intervention Type: DRUG

Oral tablet

Androgen deprivation therapy

Intervention Type: OTHER

All subjects must undergo continuous Androgen deprivation therapy with GnRH agonist/antagonist or bilateral orchiectomy during the study period.

Interventions

Enzalutamide

Oral Capsule

Intervention Type: DRUG

Flutamide

Oral tablet

Intervention Type: DRUG

Androgen deprivation therapy

All subjects must undergo continuous Androgen deprivation therapy with GnRH agonist/antagonist or bilateral orchiectomy during the study period.

Intervention Type: OTHER

Other Intervention Names

Xtandi; MDV3100

Eligibility Criteria

Inclusion Criteria

• Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small-cell histology.
• Subject on continuous ADT with Gonadotropin Releasing Hormone (GnRH) agonist/antagonist or bilateral orchiectomy.
• Serum testosterone level below the target level at screening visit.
• Subject with asymptomatic or mildly symptomatic prostate cancer.
• Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Subject has progression of the disease as defined by rising PSA levels or progressive soft tissue or bony disease during CAB therapy in combination of bicalutamide and ADT.
• A sexually active male subject and the subject's female partner who is of childbearing potential must use 2 acceptable birth control methods from screening to 3 months after the last dose of the study drug.
• Subject must agree not to donate sperm from screening to 3 months after the last dose of the study drug.

Exclusion Criteria

• Subject with severe concurrent diseases, infections, or complications.
• Subject with confirmed or suspected brain metastasis or active leptomeningeal metastasis.
• Subject with a history of malignant tumor other than prostate cancer in the past 5 years.
• Subject hypersensitive to the ingredients of enzalutamide capsules or flutamide tablets.
• Subject with a history of convulsive attack, or prone to convulsive attack.
• Subject with liver disorder such as viral hepatitis and hepatic cirrhosis, or subject with Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) at screening visit higher than the upper limit of normal.
• Subject received treatment for prostate cancer with cytocidal chemotherapy that includes anti androgenic agents other than bicalutamide, abiraterone, or estramustine.

• Minimum Eligible Age: 20 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

Site JP00024

Nagoya, Aichi-ken, Japan

Site JP00025

Nagoya, Aichi-ken, Japan

Site JP00038

Matsuyama, Ehime, Japan

Site JP00051

Iizuka, Fukuoka, Japan

Site JP00045

Isesaki, Gunma, Japan

Site JP00005

Maebashi, Gunma, Japan

Site JP00043

Ōta, Gunma, Japan

Site JP00054

Hakodate, Hokkaido, Japan

Site JP00001

Sapporo, Hokkaido, Japan

Site JP00002

Sapporo, Hokkaido, Japan

Site JP00048

Sapporo, Hokkaido, Japan

Site JP00055

Mito, Ibaraki, Japan

Site JP00019

Sagamihara, Kanagawa, Japan

Site JP00020

Yokohama, Kanagawa, Japan

Site JP00021

Yokohama, Kanagawa, Japan

Site JP00044

Yokosuka, Kanagawa, Japan

Site JP00046

Kashihara, Nara, Japan

Site JP00033

Kurashiki, Okayama-ken, Japan

Site JP00028

Hirakata, Osaka, Japan

Site JP00030

Sayama, Osaka, Japan

Site JP00027

Suita, Osaka, Japan

Site JP00009

Kitaadachi-gun, Saitama, Japan

Site JP00022

Hamamatsu, Shizuoka, Japan

Site JP00049

Utsunomiya, Tochigi, Japan

Site JP00011

Bunkyo-ku, Tokyo, Japan

Site JP00017

Bunkyo-ku, Tokyo, Japan

Site JP00013

Koto-ku, Tokyo, Japan

Site JP00014

Nakano-ku, Tokyo, Japan

Site JP00016

Shinagawa-ku, Tokyo, Japan

Site JP00018

Shinjuku-ku, Tokyo, Japan

Site JP00034

Ube, Yamaguchi, Japan

Site JP00010

Chiba, , Japan

Site JP00053

Chiba, , Japan

Site JP00039

Fukuoka, , Japan

Site JP00040

Fukuoka, , Japan

Site JP00050

Fukuoka, , Japan

Site JP00035

Hiroshima, , Japan

Site JP00026

Kyoto, , Japan

Site JP00006

Nagano, , Japan

Site JP00008

Nagano, , Japan

Site JP00041

Nagasaki, , Japan

Site JP00029

Osaka, , Japan

Site JP00031

Osaka, , Japan

Site JP00032

Osaka, , Japan

Site JP00042

Saga, , Japan

Site JP00037

Tokushima, , Japan

Site JP00052

Toyama, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://astellasclinicalstudyresults.com/hcp/study.aspx?ID=402

Link to results on the Astellas Clinical Study Results website.

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217491&parentIdentifier=9785-MA-3051&attachmentIdentifier=f355cf0d-cc7a-43df-bbfa-a7e32208d80a&fileName=9785-MA-3051_Plain_language_summary_JP.pdf&versionIdentifier=

Related Info

Other Identifiers

9785-MA-3051

Identifier Type: -

Identifier Source: org_study_id