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Docetaxel in the Treatment of Hormone Refractory Prostate Cancer

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: January 18, 2006
Last updated: December 4, 2009
Last verified: December 2009
Evaluation of safety and efficacy of docetaxel in the treatment of advanced hormone refractory prostate cancer under the conditions of daily practise.

Condition Intervention Phase
Prostatic Neoplasms Drug: docetaxel Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV Study of Safety and Efficacy of Docetaxel in Combination With Prednisone in Advanced Hormone Refractory Prostate Cancer Treatment

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • PSA decline [ Time Frame: after each docetaxel administration and after the end of treatment ]
  • pain response [ Time Frame: after each docetaxel administration and after the end of treatment ]
  • side effects occurrence [ Time Frame: Throughout the study ]

Estimated Enrollment: 30
Study Start Date: January 2006
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single group Drug: docetaxel
Docetaxel 75mg/m2/q3wx10 cycles with Prednisone 10mg/d/bid


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter :

Inclusion Criteria:

  • Patients with advanced prostate cancer, without previous chemotherapy, progressing on hormonal treatment, performance status 1 to 2

Exclusion Criteria:

  • Other cytostatic treatment, other malignity, severe comorbidity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00280098

Czech Republic
Prague, Czech Republic
Sponsors and Collaborators
Study Director: Zuzana MD Priborska Sanofi
  More Information

Responsible Party: Zuzana MD Priborska, Study Director, sanofi-aventis Identifier: NCT00280098     History of Changes
Other Study ID Numbers: XRP6976J_4001
Study First Received: January 18, 2006
Last Updated: December 4, 2009

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal processed this record on August 18, 2017