Original Article

International Journal of Clinical Oncology

, Volume 18, Issue 2, pp 306-313

First online:

Prolonged treatment with three-weekly docetaxel plus daily prednisolone for metastatic castration-resistant prostate cancer: a multicenter, phase II, open-label, non-comparative, extension study in Japan

  • Kazuo NishimuraAffiliated withDepartment of Urology, Osaka Medical Center for Cancer and Cardiovascular Diseases Email author 
  • , Norio NonomuraAffiliated withDepartment of Urology, Osaka University Graduate School of Medicine
  • , Katsuyoshi HashineAffiliated withDepartment of Urology, National Hospital Organization, Shikoku Cancer Center
  • , Hiro-omi KanayamaAffiliated withDepartment of Urology, Institute of Health Biosciences, The University of Tokushima Graduate School
  • , Seiichiro OzonoAffiliated withDepartment of Urology, Hamamatsu University School of Medicine
  • , Takeshi MiuraAffiliated withDepartment of Urology, Kanagawa Cancer Center Hospital
  • , Tsuneharu MikiAffiliated withDepartment of Urology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
  • , Yoshiyuki KakehiAffiliated withDepartment of Urology, Kagawa University Faculty of Medicine
  • , Yoichi AraiAffiliated withDepartment of Urology, Tohoku University School of Medicine
    • , Osamu OgawaAffiliated withDepartment of Urology, Kyoto University Graduate School of Medicine
    • , Ryuji FujitaAffiliated withDepartment of Urology, Iwakuni Clinical Center
    • , Katsuya NonomuraAffiliated withDepartment of Urology, Hokkaido University Graduate School of Medicine
    • , Atsushi MizokamiAffiliated withDepartment of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medicine Sciences
    • , Senji HoshiAffiliated withDepartment of Urology, Yamagata Prefectural Central Hospital
    • , Hideyuki AkazaAffiliated withDepartment of Strategic Investigation on Comprehensive Cancer Network, Research Center for Advanced Science and Technology, The University of Tokyo

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There are few reports of long-term treatment with docetaxel in castration-resistant prostate cancer (CRPC) because of the limit of a maximum of ten cycles of treatment in TAX327 showing a survival benefit. Therefore, this study, ARD6563, was conducted to evaluate the safety of more than ten cycles of docetaxel in metastatic CRPC.


We enrolled patients who had received ten cycles of docetaxel in the preceding study, ARD6562. For ARD6563, patients received docetaxel every 3 weeks, at the last dose (70, 60, or 50 mg/m2) received for cycle 10 in ARD6562, with prednisolone 5 mg orally twice daily.


The safety analysis set comprised 15 patients (median age, 64 years; performance status, 0 in 87%) out of 43 patients treated in ARD6562. The median initial dose of docetaxel was 60 mg/m2, and the median number of additional cycles administered was 8 (range, 1–42). The relative dose intensity was 78.0% for docetaxel and 98.0% for prednisolone. Dose reduction was needed in 3 cycles because of grade 3 infection, febrile neutropenia, and grade 2 neuropathy. Administration delay was necessitated in 6 cycles because of grade 1–2 nonhematological toxicities. The major grade 3–4 toxicities were myelosuppression. Five patients who had an observed partial response or stable disease in ARD6562 maintained their clinical response in ARD6563. The study treatment was discontinued in 10 patients because of disease progression and in 4 patients for serious toxicities. There were no treatment-related deaths.


Long-term docetaxel with prednisolone is feasible in selected Japanese patients with CRPC.


Docetaxel Prednisolone Prostate cancer Castration-resistant Extension study Japan