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

November 29, 2010 updated by: Sanofi

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

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.

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
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
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
Before first cycle, every 2 cycles throughout the treatment period, at the study end and first follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: José Taboada, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

June 24, 2008

First Submitted That Met QC Criteria

June 25, 2008

First Posted (Estimate)

June 26, 2008

Study Record Updates

Last Update Posted (Estimate)

November 30, 2010

Last Update Submitted That Met QC Criteria

November 29, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

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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