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

Phase 3

Terminated

• Conditions: Prostatic Neoplasms
• Interventions: Drug: Docetaxel + Prednisone; Drug: Docetaxel + Estramustine + Hydrocortisone

• Registration Number: NCT00705822
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2008-06-24
• Study First Submitted QC: 2008-06-25
• Study First Posted: 2008-06-26
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-29
• Last Update Posted: 2010-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Docetaxel + Prednisone	Docetaxel + Prednisone
1	Docetaxel + Estramustine + Hydrocortisone	Docetaxel + Estramustine + Hydrocortisone

Primary Outcome Measures

Name	Time	Method
Response rate over 50% in PSA	every 3 weeks up to end of treatment and every month until PSA progression

Secondary Outcome Measures

Name	Time	Method
Time to treatment failure	from Informed Consent signature up to end of the study
Time to progression	from Informed Consent signature up to study end
Overall and specific cause surveillance	from Informed Consent signature up to study end
Toxicity profile	from Informed Consent signature up to study end
Patients' Quality of Life	Before first cycle, every 2 cycles throughout the treatment period, at the study end and first follow-up visit

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇪🇸 Barcelona, Spain