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OpenTrials
Completed

NCT Number: NCT00280098

Docetaxel in the Treatment of Hormone Refractory Prostate Cancer

Evaluation of safety and efficacy of docetaxel in the treatment of advanced hormone refractory prostate cancer under the conditions of daily practise.

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Prague, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

docetaxel

Drug

Docetaxel 75mg/m2/q3wx10 cycles with Prednisone 10mg/d/bid

Primary outcomes

  1. PSA decline

    Time frame: after each docetaxel administration and after the end of treatment

  2. pain response

    Time frame: after each docetaxel administration and after the end of treatment

  3. side effects occurrence

    Time frame: Throughout the study

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Phase IV Study of Safety and Efficacy of Docetaxel in Combination With Prednisone in Advanced Hormone Refractory Prostate Cancer Treatment

Important dates

Study start
2006
Primary completion
2007
First posted
Jan 20, 2006
Registry last updated
Dec 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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