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Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer Who Have Relapse in Biochemistry Whilst Androgenic Blockage


Phase 3
18 Years
75 Years
Not Enrolling
Male
Prostatic Neoplasms

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Trial Information

Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer Who Have Relapse in Biochemistry Whilst Androgenic Blockage


Inclusion Criteria:



- Histological or cytological confirmation of prostate adenocarcinoma

- Advanced prostate carcinoma.

- Previous treatment with hormones

- Levels of testosterone < 50 ng/dL

- Good hematological, liver and kidney function

- Previous treatment with surgery or radiotherapy, at least 4 weeks since end of
treatment is allowed (the patient should have been recovered from any side effects.

Exclusion Criteria:

- Previous chemotherapy (estramustine included).

- Second line hormonotherapy (oestrogens, gestagens, ketoconazole, ...included)

- Previous treatment with radiotherapy (isotopes) or previous radiotherapy over > 25%
of the marrow

- Any malignant process with a free disease interval under 5 years, exception done to
non-melanoma skin cancer.

- Concomitant serious diseases

- Concomitant treatment with any other neoplassic therapy (exception done to LHRH
agonists and/or biphosphonates).

- Contraindication for the treatment with estramustine.

- Previous history of pulmonary embolism, thromboembolic disease, previous treatment
with anticoagulants (except aspirin), active thrombophlebitis or hypercoagulation.

- Previous history of pulmonary spillage or ascitis.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate over 50% in PSA

Outcome Time Frame:

every 3 weeks up to end of treatment and every month until PSA progression

Safety Issue:

No

Principal Investigator

José Taboada

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Spain: Spanish Agency of Medicines

Study ID:

XRP6976J_3502

NCT ID:

NCT00705822

Start Date:

August 2006

Completion Date:

July 2009

Related Keywords:

  • Prostatic Neoplasms
  • Neoplasms
  • Prostatic Neoplasms

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