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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00705822
• Date of registration: 24/06/2008
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer PROSTATA
• Scientific title: Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer Who Have Relapse in Biochemistry Whilst Androgenic Blockage
• Date of first enrolment: August 2006
• Target sample size: 54
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00705822
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Spain

Contacts

• Name: José Taboada
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Prostatic Neoplasms

Intervention(s)

Drug: Docetaxel + Prednisone

Drug: Docetaxel + Estramustine + Hydrocortisone

Primary Outcome(s)

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

Secondary Outcome(s)

Time to progression [Time Frame: from Informed Consent signature up to study end]

Time to treatment failure [Time Frame: from Informed Consent signature up to end of the study]

Toxicity profile [Time Frame: from Informed Consent signature up to study end]

Overall and specific cause surveillance [Time Frame: 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]

Secondary ID(s)

XRP6976J_3502

EudraCT #: 2004-003885-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors