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

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ClinicalTrials.gov Identifier: NCT00705822
Recruitment Status : Terminated (low recruitment rate)
First Posted : June 26, 2008
Last Update Posted : November 30, 2010
Sponsor:
Information provided by:
Sanofi

Study Description
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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


Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Docetaxel + Estramustine + Hydrocortisone Drug: Docetaxel + Prednisone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer Who Have Relapse in Biochemistry Whilst Androgenic Blockage
Study Start Date : August 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Docetaxel + Estramustine + Hydrocortisone
 Drug: 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
 Drug: Docetaxel + Prednisone
Docetaxel iv 80 mg + oral prednisone-pills 5 mg. Combination of these 2 drugs every 3 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Response rate over 50% in PSA [ Time Frame: every 3 weeks up to end of treatment and every month until PSA progression ]

Secondary Outcome Measures :
  1. Time to treatment failure [ Time Frame: from Informed Consent signature up to end of the study ]
  2. Time to progression [ Time Frame: from Informed Consent signature up to study end ]
  3. Overall and specific cause surveillance [ Time Frame: from Informed Consent signature up to study end ]
  4. Toxicity profile [ Time Frame: from Informed Consent signature up to study end ]
  5. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00705822


Locations
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Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: José Taboada Sanofi
More Information
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Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00705822     History of Changes
Other Study ID Numbers: XRP6976J_3502
EudraCT #: 2004-003885-14
First Posted: June 26, 2008    Key Record Dates
Last Update Posted: November 30, 2010
Last Verified: November 2010
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Hydrocortisone 17-butyrate 21-propionate
Genital Diseases, Male
Prostatic Diseases
Prednisone
Hydrocortisone
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Docetaxel
Estramustine
 Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Alkylating
Alkylating Agents