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


Phase 4
18 Years
N/A
Not Enrolling
Male
Prostatic Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA decline

Outcome Time Frame:

after each docetaxel administration and after the end of treatment

Safety Issue:

No

Principal Investigator

Zuzana MD Priborska

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Czech Republic: State Institute for Drug Control

Study ID:

XRP6976J_4001

NCT ID:

NCT00280098

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Prostatic Neoplasms
  • Neoplasms
  • Prostatic Neoplasms

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