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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02346578
Recruitment Status : Completed
First Posted : January 27, 2015
Last Update Posted : January 23, 2019
Astellas Pharma Inc
Information provided by (Responsible Party):
Taro Iguchi, MD, PHD, Osaka City University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Castration-resistant Prostate Cancer Drug: Enzalutamide Drug: Flutamide Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Prospective, Randomised and Comparative Study of AA Therapy and Early Administrating Enzalutamide in Participants With CRPC Previously Treated With CAB Therapy Using Bicalutamide.
Study Start Date : December 2014
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : January 22, 2019

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Percentage of participants whose prostate specific antigen (PSA) decreased 50 percent or more at month 3 [ Time Frame: Month 3 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02346578

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Osaka City University Graduate School of Medicine
Osaka, Japan
Sponsors and Collaborators
Taro Iguchi, MD, PHD
Astellas Pharma Inc
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Taro Iguchi, MD, PHD, Osaka City University Graduate School of Medicine, Osaka City University Identifier: NCT02346578    
Other Study ID Numbers: OCUU-CRPC
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents