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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00280098 |
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Date of registration:
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18/01/2006 |
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Primary sponsor: |
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Public title:
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Docetaxel in the Treatment of Hormone Refractory Prostate Cancer
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Scientific title:
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Phase IV Study of Safety and Efficacy of Docetaxel in Combination With Prednisone in Advanced Hormone Refractory Prostate Cancer Treatment |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00280098 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Czech Republic
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Contacts
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Name:
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Zuzana MD Priborska |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi-Aventis |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostatic Neoplasms
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Intervention(s)
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Drug: docetaxel
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Primary Outcome(s)
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pain response
[Time Frame: after each docetaxel administration and after the end of treatment]
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PSA decline
[Time Frame: after each docetaxel administration and after the end of treatment]
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side effects occurrence
[Time Frame: Throughout the study]
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Secondary ID(s)
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XRP6976J_4001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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