NCT00705822

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 30, 2010

Status Verified

November 1, 2010

Enrollment Period

2.9 years

First QC Date

June 24, 2008

Last Update Submit

November 29, 2010

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Response rate over 50% in PSA

    every 3 weeks up to end of treatment and every month until PSA progression

Secondary Outcomes (5)

  • Time to treatment failure

    from Informed Consent signature up to end of the study

  • Time to progression

    from Informed Consent signature up to study end

  • Overall and specific cause surveillance

    from Informed Consent signature up to study end

  • Toxicity profile

    from Informed Consent signature up to study end

  • Patients' Quality of Life

    Before first cycle, every 2 cycles throughout the treatment period, at the study end and first follow-up visit

Study Arms (2)

1

EXPERIMENTAL

Docetaxel + Estramustine + Hydrocortisone

Drug: Docetaxel + Estramustine + Hydrocortisone

2

ACTIVE COMPARATOR

Docetaxel + Prednisone

Drug: Docetaxel + Prednisone

Interventions

Docetaxel + Estramustine + HydrocortisoneDRUG

Docetaxel iv 80 mg + Oral estramustine-pills 140 mg + Oral hydrocortisone-pills 20 mg. Combination of these 3 drugs every 3 weeks

1
Docetaxel + PrednisoneDRUG

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

2

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Barcelona, Spain

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

DocetaxelEstramustineHydrocortisonePrednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedEstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnenedionesPregnenesPregnanes11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-HydroxycorticosteroidsPregnadienediolsPregnadienes

Study Officials

  • José Taboada

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 24, 2008

First Posted

June 26, 2008

Study Start

August 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

November 30, 2010

Record last verified: 2010-11

Locations

ES(1)