International Journal of Clinical Oncology

, Volume 18, Issue 2, pp 306–313 | Cite as

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 Nishimura
  • Norio Nonomura
  • Katsuyoshi Hashine
  • Hiro-omi Kanayama
  • Seiichiro Ozono
  • Takeshi Miura
  • Tsuneharu Miki
  • Yoshiyuki Kakehi
  • Yoichi Arai
  • Osamu Ogawa
  • Ryuji Fujita
  • Katsuya Nonomura
  • Atsushi Mizokami
  • Senji Hoshi
  • Hideyuki Akaza
Original Article



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 


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Copyright information

© Japan Society of Clinical Oncology 2012

Authors and Affiliations

  • Kazuo Nishimura
    • 1
  • Norio Nonomura
    • 2
  • Katsuyoshi Hashine
    • 3
  • Hiro-omi Kanayama
    • 4
  • Seiichiro Ozono
    • 5
  • Takeshi Miura
    • 6
  • Tsuneharu Miki
    • 7
  • Yoshiyuki Kakehi
    • 8
  • Yoichi Arai
    • 9
  • Osamu Ogawa
    • 10
  • Ryuji Fujita
    • 11
  • Katsuya Nonomura
    • 12
  • Atsushi Mizokami
    • 13
  • Senji Hoshi
    • 14
  • Hideyuki Akaza
    • 15
  1. 1.Department of UrologyOsaka Medical Center for Cancer and Cardiovascular DiseasesOsakaJapan
  2. 2.Department of UrologyOsaka University Graduate School of MedicineSuitaJapan
  3. 3.Department of UrologyNational Hospital Organization, Shikoku Cancer CenterMatsuyamaJapan
  4. 4.Department of UrologyInstitute of Health Biosciences, The University of Tokushima Graduate SchoolTokushimaJapan
  5. 5.Department of UrologyHamamatsu University School of MedicineHamamatsuJapan
  6. 6.Department of UrologyKanagawa Cancer Center HospitalYokohamaJapan
  7. 7.Department of UrologyGraduate School of Medical Science, Kyoto Prefectural University of MedicineKyotoJapan
  8. 8.Department of UrologyKagawa University Faculty of MedicineKagawaJapan
  9. 9.Department of UrologyTohoku University School of MedicineSendaiJapan
  10. 10.Department of UrologyKyoto University Graduate School of MedicineKyotoJapan
  11. 11.Department of UrologyIwakuni Clinical CenterIwakuniJapan
  12. 12.Department of UrologyHokkaido University Graduate School of MedicineSapporoJapan
  13. 13.Department of Integrative Cancer Therapy and UrologyKanazawa University Graduate School of Medicine SciencesKanazawaJapan
  14. 14.Department of UrologyYamagata Prefectural Central HospitalYamgataJapan
  15. 15.Department of Strategic Investigation on Comprehensive Cancer Network, Research Center for Advanced Science and TechnologyThe University of TokyoTokyoJapan

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