Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer (PROSTATA)

Sanofi

Status and phase: Terminated; Phase 3

Conditions: Prostatic Neoplasms

Treatments: Drug: Docetaxel + Prednisone; Drug: Docetaxel + Estramustine + Hydrocortisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00705822

EudraCT #: 2004-003885-14

XRP6976J_3502

Details and patient eligibility

About

To compare the efficacy of both strategies (reference treatment: Docetaxel+Prednisone and experimental treatment: Docetaxel+Estramustine+Hydrocortisone) by means of PSA values.

To determine the time to treatment failure in both strategies To determine the overall and specific cause survival To evaluate the safety profile To analyze the Quality of Life

Enrollment: 54 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

1

Experimental group

Description:

Docetaxel + Estramustine + Hydrocortisone

Treatment:

Drug: Docetaxel + Estramustine + Hydrocortisone

2

Active Comparator group

Description:

Docetaxel + Prednisone

Treatment:

Drug: Docetaxel + Prednisone