Clinical trial NCT00705822: Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Prostatic Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-06-26
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Response rate over 50% in PSA
timeFrame: every 3 weeks up to end of treatment and every month until PSA progression
Secondary outcomes:
measure: Time to treatment failure
timeFrame: from Informed Consent signature up to end of the study
measure: Time to progression
timeFrame: from Informed Consent signature up to study end
measure: Overall and specific cause surveillance
timeFrame: from Informed Consent signature up to study end
measure: Toxicity profile
timeFrame: from Informed Consent signature up to study end
measure: Patients' Quality of Life
timeFrame: Before first cycle, every 2 cycles throughout the treatment period, at the study end and first follow-up visit
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: José Taboada
role: STUDY_DIRECTOR
References: