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

Prostatic Neoplasms Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00705822
• Other study ID #: XRP6976J_3502
• Secondary ID: EudraCT #: 2004-
• Status: Terminated
• Phase: Phase 3
• First received: June 24, 2008
• Last updated: November 29, 2010
• Start date: August 2006
• Est. completion date: July 2009

Study information

• Verified date: November 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

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
• Docetaxel + Prednisone
Docetaxel iv 80 mg + oral prednisone-pills 5 mg. Combination of these 2 drugs every 3 weeks.

Locations

Country	Name	City	State
Spain	Sanofi-Aventis Administrative Office	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate over 50% in PSA		every 3 weeks up to end of treatment and every month until PSA progression	No
Secondary	Time to treatment failure		from Informed Consent signature up to end of the study	No
Secondary	Time to progression		from Informed Consent signature up to study end	No
Secondary	Overall and specific cause surveillance		from Informed Consent signature up to study end	Yes
Secondary	Toxicity profile		from Informed Consent signature up to study end	Yes
Secondary	Patients' Quality of Life		Before first cycle, every 2 cycles throughout the treatment period, at the study end and first follow-up visit	No