Comparative Study of Alternative Antiandrogen (AA) Therapy and Early Initiating of Enzalutamide for Castration-resistant Prostate Cancer (CRPC) After Combined Androgen Blockade (CAB) Therapy.
NCT ID: NCT02346578
Last Updated: 2021-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
104 participants
INTERVENTIONAL
2014-12-31
2019-01-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Enzalutamide
Enzalutamide 160 mg administered orally once a day as four 40-mg soft capsules
Enzalutamide
Flutamide
Flutamide 125 mg administered orally three times a day as one tablet after meal
Flutamide
Interventions
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Enzalutamide
Flutamide
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
MALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Taro Iguchi, MD, PHD
OTHER
Responsible Party
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Taro Iguchi, MD, PHD
Osaka City University Graduate School of Medicine
Locations
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Osaka City University Graduate School of Medicine
Osaka, , Japan
Countries
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References
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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.
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.
Other Identifiers
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OCUU-CRPC
Identifier Type: -
Identifier Source: org_study_id
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