NCT02346578

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2019

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

3.8 years

First QC Date

January 15, 2015

Last Update Submit

September 8, 2021

Conditions

Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

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

    Month 3

Secondary Outcomes (5)

  • Percentage of participants whose PSA decreased 50 percent or more at month 6

    Month 6

  • Percentage of participants who showed disease progression at month 3

    Month 3

  • Percentage of participants who showed disease progression at month 6

    Month 6

  • PSA progression-free survival (PFS)

    Up to 39 months

  • QOL measured by functional assessment of cancer therapy-prostate (FACT-P)

    Up to 39 months

Study Arms (2)

Enzalutamide

EXPERIMENTAL

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

Drug: Enzalutamide

Flutamide

ACTIVE COMPARATOR

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

Drug: Flutamide

Interventions

EnzalutamideDRUG
Enzalutamide
FlutamideDRUG
Flutamide

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osaka City University Graduate School of Medicine

Osaka, Japan

Location

Related Publications (2)

  • 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.

    PMID: 30971225BACKGROUND

  • 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.

    PMID: 31564004RESULT

MeSH Terms

Interventions

enzalutamideFlutamide

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Osaka City University Graduate School of Medicine

Study Record Dates

First Submitted

January 15, 2015

First Posted

January 27, 2015

Study Start

December 1, 2014

Primary Completion

September 30, 2018

Study Completion

January 22, 2019

Last Updated

September 16, 2021

Record last verified: 2021-09

Locations

JP(1)