Clinical trial · Interventional
Comparative Study of Alternative Antiandrogen (AA) Therapy and Early Initiating of Enzalutamide for Castration-resistant Prostate Cancer (CRPC) After Combined Androgen Blockade (CAB) Therapy.
Multicenter, Prospective, Randomised and Comparative Study of AA Therapy and Early Administrating Enzalutamide in Participants With CRPC Previously Treated With CAB Therapy Using Bicalutamide.
NCT02346578CI-TRIAL-00053920completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enzalutamide | Drug | Enzalutamide | ALIAS |
| Flutamide | Drug | Flutamide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Enzalutamide
- description
- Enzalutamide 160 mg administered orally once a day as four 40-mg soft capsules
- interventionNames
- Drug: Enzalutamide
- type
- ACTIVE_COMPARATOR
- label
- Flutamide
- description
- Flutamide 125 mg administered orally three times a day as one tablet after meal
- interventionNames
- Drug: Flutamide
Primary outcomes (1)
- measure
- Percentage of participants whose prostate specific antigen (PSA) decreased 50 percent or more at month 3
- timeFrame
- Month 3
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDIguchi 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 30971225
- RESULTIguchi 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 31564004