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

This study has been terminated.
(low recruitment rate)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00705822
First received: June 24, 2008
Last updated: November 29, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Prostatic Neoplasms
Drug: Docetaxel + Estramustine + Hydrocortisone
Drug: Docetaxel + Prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Response rate over 50% in PSA [ Time Frame: every 3 weeks up to end of treatment and every month until PSA progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to treatment failure [ Time Frame: from Informed Consent signature up to end of the study ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: from Informed Consent signature up to study end ] [ Designated as safety issue: No ]
  • Overall and specific cause surveillance [ Time Frame: from Informed Consent signature up to study end ] [ Designated as safety issue: Yes ]
  • Toxicity profile [ Time Frame: from Informed Consent signature up to study end ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: August 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705822

Locations
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sponsors and Collaborators
Sanofi
Investigators
Study Director: José Taboada Sanofi
  More Information

No publications provided

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
Study First Received: June 24, 2008
Last Updated: November 29, 2010
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Estramustine
Prednisone
Docetaxel
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone
Hydrocortisone-17-butyrate
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal
Anti-Inflammatory Agents
Dermatologic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents

ClinicalTrials.gov processed this record on August 28, 2014