Back to resultsCombination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer (PROSTATA)
Primary Purpose
Prostatic Neoplasms
Status
Terminated
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Docetaxel + Estramustine + Hydrocortisone
Docetaxel + Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms
Eligibility 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.
Sites / Locations
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Docetaxel + Estramustine + Hydrocortisone
Docetaxel + Prednisone
Outcomes
Primary Outcome Measures
Response rate over 50% in PSA
Secondary Outcome Measures
Time to treatment failure
Time to progression
Overall and specific cause surveillance
Toxicity profile
Patients' Quality of Life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00705822
Brief Title
Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer
Acronym
PROSTATA
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 Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Terminated
Why Stopped
low recruitment rate
Study Start Date
August 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Docetaxel + Estramustine + Hydrocortisone
Arm Title
2
Arm Type
Active Comparator
Arm Description
Docetaxel + Prednisone
Intervention Type
Drug
Intervention Name(s)
Docetaxel + Estramustine + Hydrocortisone
Intervention Description
Docetaxel iv 80 mg + Oral estramustine-pills 140 mg + Oral hydrocortisone-pills 20 mg.
Combination of these 3 drugs every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Docetaxel + Prednisone
Intervention Description
Docetaxel iv 80 mg + oral prednisone-pills 5 mg. Combination of these 2 drugs every 3 weeks.
Primary Outcome Measure Information:
Title
Response rate over 50% in PSA
Time Frame
every 3 weeks up to end of treatment and every month until PSA progression
Secondary Outcome Measure Information:
Title
Time to treatment failure
Time Frame
from Informed Consent signature up to end of the study
Title
Time to progression
Time Frame
from Informed Consent signature up to study end
Title
Overall and specific cause surveillance
Time Frame
from Informed Consent signature up to study end
Title
Toxicity profile
Time Frame
from Informed Consent signature up to study end
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Taboada
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Barcelona
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer
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