Comparative Study of Alternative Antiandrogen (AA) Therapy and Early Initiating of Enzalutamide for Castration-resistant Prostate Cancer (CRPC) After Combined Androgen Blockade (CAB) Therapy.

September 8, 2021 updated by: Taro Iguchi, MD, PHD

Multicenter, Prospective, Randomised and Comparative Study of AA Therapy and Early Administrating Enzalutamide in Participants With CRPC Previously Treated With CAB Therapy Using Bicalutamide.

The objective of this study is to compare the efficacy and safety of enzalutamide or alternative AA therapy in CRPC participants who were previously treated with a combined androgen blockade therapy which included bicalutamide (Bic-CAB). Efficacy and safety of enzalutamide and alternative AA therapy will be evaluated, and effective therapy against CRPC after treatment with Bic-CAB will be investigated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan
        • Osaka City University Graduate School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Testosterone of less than 50 ng/dL
  • Participants who was detected of disease progression on image or relapse of PSA (All PSA values measured 3 time at least one week interval are consecutively increased and final value is 2 ng/mL or more. If third value is not higher than second one, fourth measurement will be undertaken and its value must be higher than second one.)
  • Participants who relapsed after CAB with bicalutamide
  • Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1
  • Aged 20 years or older
  • Participants who provided written informed consent

Exclusion Criteria:

  • Any prior treatment with enzalutamide, flutamide, abiraterone or chemotherapy, except for neoadjuvant therapy
  • With active double cancer
  • Any prior treatment with bicalutamide within 6 weeks
  • Participants who received systemic biological therapy (except for existing approved drug for bone or treatment with luteinizing hormone-releasing hormone (LHRH) analogue) or received treatment with other antitumor agent for prostate cancer
  • With serious complication
  • History of hypersensitivity to enzalutamide or any other excipient of enzalutamide
  • History of hypersensitivity to flutamide-containing agent
  • With liver dysfunction
  • Participants who are considered as inadequate by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Enzalutamide
Enzalutamide 160 mg administered orally once a day as four 40-mg soft capsules
Drug: Enzalutamide
ACTIVE_COMPARATOR: Flutamide
Flutamide 125 mg administered orally three times a day as one tablet after meal
Drug: Flutamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants whose prostate specific antigen (PSA) decreased 50 percent or more at month 3
Time Frame: Month 3
Month 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants whose PSA decreased 50 percent or more at month 6
Time Frame: Month 6
Month 6
Percentage of participants who showed disease progression at month 3
Time Frame: Month 3
Month 3
Percentage of participants who showed disease progression at month 6
Time Frame: Month 6
Month 6
PSA progression-free survival (PFS)
Time Frame: Up to 39 months
Up to 39 months
QOL measured by functional assessment of cancer therapy-prostate (FACT-P)
Time Frame: Up to 39 months
Up to 39 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taro Iguchi, MD, PHD

Collaborators

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (ACTUAL)

September 30, 2018

Study Completion (ACTUAL)

January 22, 2019

Study Registration Dates

First Submitted

January 15, 2015

First Submitted That Met QC Criteria

January 20, 2015

First Posted (ESTIMATE)

January 27, 2015

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 8, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCUU-CRPC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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