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

Castration-resistant Prostate Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02346578
• Other study ID #: OCUU-CRPC
• Status: Completed
• Phase: Phase 2
• Start date: December 2014
• Est. completion date: January 22, 2019

Study information

• Verified date: September 2021
• Source: Osaka City University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 22, 2019
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Enzalutamide

• Flutamide

Locations

Country	Name	City	State
Japan	Osaka City University Graduate School of Medicine	Osaka

Sponsors (2)

Lead Sponsor	Collaborator
Taro Iguchi, MD, PHD	Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

References & Publications (2)

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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants whose prostate specific antigen (PSA) decreased 50 percent or more at month 3		Month 3
Secondary	Percentage of participants whose PSA decreased 50 percent or more at month 6		Month 6
Secondary	Percentage of participants who showed disease progression at month 3		Month 3
Secondary	Percentage of participants who showed disease progression at month 6		Month 6
Secondary	PSA progression-free survival (PFS)		Up to 39 months
Secondary	QOL measured by functional assessment of cancer therapy-prostate (FACT-P)		Up to 39 months