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Investigation of clinical efficacy of Enzalutamide and its predictive factors in CRPC patients

Investigation of clinical efficacy of Enzalutamide and its predictive factors in CRPC patients - Efficacy of Enzalutamide in CRPC patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015996
Enrollment
50
Registered
2014-12-23
Start date
2014-12-22
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

castration resistant prostate cancer

Interventions

Treatment with Enzalutamide

Sponsors

Keio University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1)CRPC patients undergoing ADT with GnRH antagonists,agonist or bilateral orchiectomy 2) Testosterone levels of less than 50 ng/dL 3) 25% increase in PSA from nadir (and by 2 ng/mL) which is confirmed 4 weeks later 4) ECOG PS 0-2 5) Signed written informed consent

Exclusion criteria

Exclusion criteria: 1) Severe cardiac function disorders, hepatic function disorders, renal function disorders, infectious disease or hematopoietic disorders 2) Hypersensitivity to study medication 3) History of seizure or any condition that may predispose to seizure 4) Age <20 years 5) History of treatment with Enzalutamide, Abiraterone or chemotherapy 6) Patients whom the investigator judges inappropriate for the study

Design outcomes

Primary

MeasureTime frame
SMAC, CBC, serum PSA, cytokines, androgens, Lipid metabolism. Bone markers, QoL assessment PSA-PFS

Countries

Japan

Contacts

Public ContactTakeo Kosaka

Keio University School of Medicine Department of Urology

takemduro@gmail.com03-5363-3825

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026