- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00705822
Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer (PROSTATA)
Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer Who Have Relapse in Biochemistry Whilst Androgenic Blockage
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Barcelona, Spain
- Sanofi-Aventis Administrative Office
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Docetaxel + Estramustine + Hydrocortisone
|
Docetaxel iv 80 mg + Oral estramustine-pills 140 mg + Oral hydrocortisone-pills 20 mg. Combination of these 3 drugs every 3 weeks |
Active Comparator: 2
Docetaxel + Prednisone
|
Docetaxel iv 80 mg + oral prednisone-pills 5 mg.
Combination of these 2 drugs every 3 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate over 50% in PSA
Time Frame: every 3 weeks up to end of treatment and every month until PSA progression
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every 3 weeks up to end of treatment and every month until PSA progression
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to treatment failure
Time Frame: from Informed Consent signature up to end of the study
|
from Informed Consent signature up to end of the study
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Time to progression
Time Frame: from Informed Consent signature up to study end
|
from Informed Consent signature up to study end
|
Overall and specific cause surveillance
Time Frame: from Informed Consent signature up to study end
|
from Informed Consent signature up to study end
|
Toxicity profile
Time Frame: from Informed Consent signature up to study end
|
from Informed Consent signature up to study end
|
Patients' Quality of Life
Time Frame: Before first cycle, every 2 cycles throughout the treatment period, at the study end and first follow-up visit
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Before first cycle, every 2 cycles throughout the treatment period, at the study end and first follow-up visit
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: José Taboada, Sanofi
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Docetaxel
- Prednisone
- Estramustine
- Hydrocortisone
Other Study ID Numbers
- XRP6976J_3502
- EudraCT #: 2004-003885-14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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