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A Study to Determine Enzalutamide Long-term Safety and Efficacy After Anti-androgen Therapy for CRPC | Clinical Trials | Clareo Health

COMPLETED

A Study to Determine Enzalutamide Long-term Safety and Efficacy After Anti-androgen Therapy for CRPC

NCT02669147•Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

View on ClinicalTrials.gov

Summary

This is a prospective observational study to evaluate effectiveness and safety of Enzalutamide for Castration Resistant Prostate Cancer (CRPC) patients who decided to administer Enzalutamide after anti-androgen therapy. CRPC Patients who are observed PSA or disease progression after anti-androgen therapy and decided to administrate Enzalutamide will dose the Enzalutamide 160 mg orally once daily and observed the practical treatment. Total research term is for 4 years, consists of 2-year case registration terms and 2-year observational terms.

Eligibility

Age

20 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Patients with histologically or cytologically confirmed prostate cancer.
•2. Patients who are receiving or received continuous androgen deprivation therapy using both gonadotropin-releasing hormone (GnRH) agonist and antagonist (medical castration), or both testicles removal by surgery (surgical castration).
•3. Castration resistant prostate cancer (CRPC) patients who are observed disease progression after castration treatment and implied the treatment resistant.
•4. CRPC patients who conducted anti-androgen alternating therapy as shown below 1) and are observed one or more of disease progression shown as below 2) during or after the therapy and decided to administer enzalutamide.
•Note 1) anti-androgen alternating therapy is defined as the therapy of flutamide administration after bicalutamide.
•Note 2) Disease progression criteria during or after anti-androgen alternating therapy
•① PSA progression during or after anti-androgen alternating therapy: PSA increased more than 25% compare to the lowest test results after initial dose of anti-androgen alternating therapy (flutamide) and the increasing is more than 2ng/ml.
•②Confirmed disease progression of soft tissue lesion defined as RECIST v1.1.
•③Confirmed disease progression of bone lesion defined as 2 or more of new appearance of bone lesion on bone scintigraphy.
•5. Patients with the Eastern Cooperative Oncology Group (ECOG) performance status 0-2
+1 more criteria

Exclusion Criteria

•1. Patients who is administering or have administration history of enzalutamide, abiraterone, docetaxel or cabazitaxel
•2. Patients with history of seizure or predisposing disease of seizure
•3. Patients with severe liver dysfunction
•4. Patients with a previous history of hypersensitivity to any component of drugs which will be administered in this study
•5. Patients who considered to be inappropriate for the study participation by the investigator

Key Dates

Start Date

January 26, 2016

Primary Completion Date

March 1, 2021

Completion Date

March 1, 2021

Last Updated

December 28, 2022

Enrollment

160

ACTUAL participants

Conditions

Castration Resistant Prostate Cancer (CRPC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 28, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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