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

• Sponsor: Sanofi (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00705822
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 1.5

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms	Drug: Docetaxel + Estramustine + Hydrocortisone; Drug: Docetaxel + Prednisone	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Aug 1, 2006
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Time to treatment failure [from Informed Consent signature up to end of the study]

2. Time to progression [from Informed Consent signature up to study end]

3. Overall and specific cause surveillance [from Informed Consent signature up to study end]

4. Toxicity profile [from Informed Consent signature up to study end]

5. Patients' Quality of Life [Before first cycle, every 2 cycles throughout the treatment period, at the study end and first follow-up visit]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Barcelona		Spain

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: José Taboada, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00705822
• Other Study ID Numbers: XRP6976J_3502; EudraCT #: 2004-003885-14
• First Posted: Jun 26, 2008
• Last Update Posted: Nov 30, 2010
• Last Verified: Nov 1, 2010

• Additional relevant MeSH terms: Prostatic Neoplasms; Prednisone; Hydrocortisone; Docetaxel; Estramustine

Study Results

No Results Posted as of Nov 30, 2010