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

Sponsor
Taro Iguchi, MD, PHD (Other)
Overall Status
Completed
CT.gov ID
NCT02346578
Collaborator
Astellas Pharma Inc (Industry)
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Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Dec 1, 2014
Actual Primary Completion Date :
Sep 30, 2018
Actual Study Completion Date :
Jan 22, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Percentage of participants whose prostate specific antigen (PSA) decreased 50 percent or more at month 3 [Month 3]

Secondary Outcome Measures

  1. Percentage of participants whose PSA decreased 50 percent or more at month 6 [Month 6]

  2. Percentage of participants who showed disease progression at month 3 [Month 3]

  3. Percentage of participants who showed disease progression at month 6 [Month 6]

  4. PSA progression-free survival (PFS) [Up to 39 months]

  5. QOL measured by functional assessment of cancer therapy-prostate (FACT-P) [Up to 39 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Osaka City University Graduate School of Medicine Osaka Japan

Sponsors and Collaborators

  • Taro Iguchi, MD, PHD
  • Astellas Pharma Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Taro Iguchi, MD, PHD, Osaka City University Graduate School of Medicine, Osaka City University
ClinicalTrials.gov Identifier:
NCT02346578
Other Study ID Numbers:
  • OCUU-CRPC
First Posted:
Jan 27, 2015
Last Update Posted:
Sep 16, 2021
Last Verified:
Sep 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2021