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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.

Primary Purpose

Castration-resistant Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Enzalutamide
Flutamide
Sponsored by
Taro Iguchi, MD, PHD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Castration-resistant Prostate Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Osaka City University Graduate School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enzalutamide

Flutamide

Arm Description

Enzalutamide 160 mg administered orally once a day as four 40-mg soft capsules

Flutamide 125 mg administered orally three times a day as one tablet after meal

Outcomes

Primary Outcome Measures

Percentage of participants whose prostate specific antigen (PSA) decreased 50 percent or more at month 3

Secondary Outcome Measures

Percentage of participants whose PSA decreased 50 percent or more at month 6
Percentage of participants who showed disease progression at month 3
Percentage of participants who showed disease progression at month 6
PSA progression-free survival (PFS)
QOL measured by functional assessment of cancer therapy-prostate (FACT-P)

Full Information

First Posted
January 15, 2015
Last Updated
September 8, 2021
Sponsor
Taro Iguchi, MD, PHD
Collaborators
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02346578
Brief Title
Comparative Study of Alternative Antiandrogen (AA) Therapy and Early Initiating of Enzalutamide for Castration-resistant Prostate Cancer (CRPC) After Combined Androgen Blockade (CAB) Therapy.
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 Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
January 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Taro Iguchi, MD, PHD
Collaborators
Astellas Pharma Inc

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Castration-resistant Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enzalutamide
Arm Type
Experimental
Arm Description
Enzalutamide 160 mg administered orally once a day as four 40-mg soft capsules
Arm Title
Flutamide
Arm Type
Active Comparator
Arm Description
Flutamide 125 mg administered orally three times a day as one tablet after meal
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Intervention Type
Drug
Intervention Name(s)
Flutamide
Primary Outcome Measure Information:
Title
Percentage of participants whose prostate specific antigen (PSA) decreased 50 percent or more at month 3
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Percentage of participants whose PSA decreased 50 percent or more at month 6
Time Frame
Month 6
Title
Percentage of participants who showed disease progression at month 3
Time Frame
Month 3
Title
Percentage of participants who showed disease progression at month 6
Time Frame
Month 6
Title
PSA progression-free survival (PFS)
Time Frame
Up to 39 months
Title
QOL measured by functional assessment of cancer therapy-prostate (FACT-P)
Time Frame
Up to 39 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Osaka City University Graduate School of Medicine
City
Osaka
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
30971225
Citation
Iguchi T, Tamada S, Kato M, Yasuda S, Yamasaki T, Nakatani T. Enzalutamide versus flutamide for castration-resistant prostate cancer after combined androgen blockade therapy with bicalutamide: study protocol for a multicenter randomized phase II trial (the OCUU-CRPC study). BMC Cancer. 2019 Apr 11;19(1):339. doi: 10.1186/s12885-019-5526-3.
Results Reference
background
PubMed Identifier
31564004
Citation
Iguchi T, Tamada S, Kato M, Yasuda S, Machida Y, Ohmachi T, Ishii K, Iwata H, Yamamoto S, Kanamaru T, Morimoto K, Hase T, Tashiro K, Harimoto K, Deguchi T, Adachi T, Iwamoto K, Takegaki Y, Nakatani T. Enzalutamide versus flutamide for castration-resistant prostate cancer after combined androgen blockade therapy with bicalutamide: the OCUU-CRPC study. Int J Clin Oncol. 2020 Mar;25(3):486-494. doi: 10.1007/s10147-019-01554-3. Epub 2019 Sep 28.
Results Reference
result

Learn more about this trial

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

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