Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
First received: March 6, 2003
Last updated: February 23, 2012
Last verified: April 2008

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective with or without chemotherapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with or without docetaxel and estramustine in treating patients who have prostate cancer that is locally advanced or at high risk of relapse.

Condition Intervention Phase
Prostate Cancer
Drug: bicalutamide
Drug: buserelin
Drug: cyproterone acetate
Drug: docetaxel
Drug: estramustine phosphate sodium
Drug: flutamide
Drug: goserelin acetate
Drug: leuprolide acetate
Drug: nilutamide
Drug: triptorelin
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Randomized Study Of Adjuvant Hormonal Therapy With And Without Docetaxel And Estramustine In Patients With Advanced Prostate Cancer Or With A High Risk Of Relapse

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Survival rate, in terms of clinical and biological remission at 8 years [ Designated as safety issue: No ]
  • Prostate-specific antigen level at 3 months [ Designated as safety issue: No ]
  • Cancer progression as measured by ultrasound [ Designated as safety issue: No ]
  • Survival without clinical remission [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: November 2002
Detailed Description:


  • Compare the 8-year survival rate, in terms of clinical and biological remission, of patients with locally advanced prostate cancer or with a high risk of relapse treated with neoadjuvant releasing factor agonist therapy and antiandrogen therapy with or without docetaxel and estramustine given before local radiotherapy or prostatectomy.
  • Compare the prostate-specific antigen level at 3 months in patients treated with these regimens.
  • Compare cancer progression by ultrasound in patients treated with these regimens.
  • Compare survival without clinical remission of patients treated with these regimens.
  • Compare the overall survival of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Gleason score (7 or under vs over 7), T stage (T1 or T2 vs T3 or T4), prostate-specific antigen level (20 ng/mL or less vs greater than 20 ng/mL), and lymph node involvement (N0 vs N1 or N2). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral antiandrogen therapy comprising nilutamide twice daily or bicalutamide once daily or flutamide 3 times daily or cyproterone 4 times daily. Patients also receive docetaxel IV over 1 hour on day 2 and estramustine on days 1-5. Treatment repeats every 21 days for a total of 4 courses. Patients also receive luteinizing hormone-releasing hormone (LHRH) therapy IV comprising buserelin subcutaneously (SC) every 2 months or triptorelin, leuprolide, or goserelin SC every 3 months.
  • Arm II: Patients receive antiandrogen and LHRH therapy as in arm I. Beginning approximately 21 days after chemotherapy is completed, patients with N0 disease undergo radiotherapy 5 days a week for 6-7 weeks or radical prostatectomy. Patients with N1 or N2 disease undergo radiotherapy or no further local treatment.

Hormonal therapy continues in both arms for 3 years in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at 3 months, and at 1 year.

Patients are followed every 6 months for 5 years.

PROJECTED ACCRUAL: A total of 250 patients (125 per treatment arm) will be accrued for this study within 3 years.


Ages Eligible for Study:   up to 79 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the prostate

    • Locally advanced disease or at high risk for relapse
  • No clinically or radiologically suspected metastases
  • Prior lymphadenectomy required
  • Meets at least 1 of the following criteria for poor prognosis:

    • Gleason score greater than 7
    • T3 or T4 disease
    • Prostate-specific antigen greater than 20 ng/mL
    • N1 disease



  • Under 80

Performance status

  • ECOG 0-2

Life expectancy

  • More than 10 years


  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • AST and ALT no greater than 1.5 times upper limit of normal (ULN)
  • Bilirubin no greater than ULN


  • Creatinine less than 1.6 mg/dL OR
  • Creatinine clearance greater than 60 mL/min


  • No uncontrolled or severe cardiovascular disease
  • No prior thrombosis


  • No prior pulmonary embolus


  • No active infection
  • No intolerance to aspirin
  • No other prior malignancy except basal cell skin cancer
  • No physical or psychological condition that would preclude study compliance


Biologic therapy

  • No concurrent immunotherapy


  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • No prior hormonal therapy
  • No other concurrent hormonal therapy


  • Not specified


  • See Disease Characteristics


  • No other concurrent anticancer therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055731

Centre Paul Papin
Angers, France, 49100
Hopital Saint Andre
Bordeaux, France, 33075
Institut Bergonie
Bordeaux, France, 33076
Hopital Ambroise Pare
Boulogne-Billancourt, France, F-92104
Centre Regional Francois Baclesse
Caen, France, 14076
Polyclinique du Parc
Cholet, France, 49300
Centre Hospitalier Universitaire Henri Mondor
Creteil, France, 94000
Clinique Sainte-Marguerite
Hyeres, France, 83400
Centre Hospitalier Departemental
La Roche Sur Yon, France, 85025
Centre Hospital Universitaire Hop Huriez
Lille, France, 59037
Centre Hospital Regional Universitaire de Limoges
Limoges, France, 87042
Polyclinique des Quatre Pavillons
Lormont, France, 33310
Centre Leon Berard
Lyon, France, 69008
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
CHU de la Timone
Marseille, France, 13385
Hopital Notre-Dame de Bon Secours
Metz, France, 57038
Hopital Clinique Claude Bernard
Metz, France, 57072
Centre Hospitalier General de Mont de Marsan
Mont-de-Marsan, France, 40000
Hopital Lapeyronie-CHU Montpellier
Montpellier, France, 34295
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Centre Catherine de Sienne
Nantes, France, 02
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France, 44805
Centre Antoine Lacassagne
Nice, France, 06189
Hopital Tenon
Paris, France, 75970
Hopital Europeen Georges Pompidou
Paris, France, 75015
Hopital de la Croix St. Simon
Paris, France, 75020
Hopital Saint Joseph
Paris, France, 75674
Institut Curie Hopital
Paris, France, 75248
Institut Jean Godinot
Reims, France, 51056
Centre Eugene Marquis
Rennes, France, 35042
Centre Hospitalier de Rodez
Rodez, France, 12027
Centre Henri Becquerel
Rouen, France, 76038
Centre Rene Huguenin
Saint Cloud, France, 92211
Hopital Foch
Suresnes, France, 92151
Institut Claudius Regaud
Toulouse, France, 31052
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, France, 37044
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Institut Gustave Roussy
Villejuif, France, F-94805
Sponsors and Collaborators
Study Chair: Karim Fizazi, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00055731     History of Changes
Other Study ID Numbers: CDR0000270970  FRE-FNCLCC-GETUG-12/0203  EU-20238 
Study First Received: March 6, 2003
Last Updated: February 23, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Cyproterone Acetate
Alkylating Agents
Androgen Antagonists
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Contraceptive Agents
Contraceptive Agents, Male
Fertility Agents
Fertility Agents, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 05, 2016