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Last Modified: 12/20/2006     First Published: 2/21/2003  
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Phase III Randomized Study of Neoadjuvant Releasing Factor Agonist Therapy and Antiandrogen Therapy With or Without Docetaxel And Estramustine in Patients With Locally Advanced Prostate Cancer or With A High Risk of Relapse

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase
 Type
 Status
 Age
 Sponsor
 Protocol IDs

Phase III
Treatment
Active
Under 80
Other
FRE-FNCLCC-GETUG-12/0203
EU-20238, NCT00055731

Objectives

  1. 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.
  2. Compare the prostate-specific antigen level at 3 months in patients treated with these regimens.
  3. Compare cancer progression by ultrasound in patients treated with these regimens.
  4. Compare survival without clinical remission of patients treated with these regimens.
  5. Compare the overall survival of patients treated with these regimens.
  6. Compare the toxicity of these regimens in these patients.
  7. Compare the quality of life of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

  • 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


Prior/Concurrent Therapy:

Biologic therapy

  • No concurrent immunotherapy

Chemotherapy

  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • No prior hormonal therapy
  • No other concurrent hormonal therapy

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics

Other

  • No other concurrent anticancer therapy

Patient Characteristics:

Age

  • Under 80

Performance status

  • ECOG 0-2

Life expectancy

  • More than 10 years

Hematopoietic

  • Absolute neutrophil count greater than 1,500/mm3
  • Platelet count at least 100,000/mm3

Hepatic

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

Renal

  • Creatinine less than 1.6 mg/dL

    OR

  • Creatinine clearance greater than 60 mL/min

Cardiovascular

  • No uncontrolled or severe cardiovascular disease
  • No prior thrombosis

Pulmonary

  • No prior pulmonary embolus

Other

  • 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

Expected Enrollment

250

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

Outcomes

Primary Outcome(s)

Survival rate, in terms of clinical and biological remission at 8 years
Prostate-specific antigen level at 3 months
Cancer progression as measured by ultrasound
Survival without clinical remission
Overall survival
Toxicity
Quality of life

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.

Published Results

Fizazi K, Gravis G, Culine S: The GETUG 12 trial, a phase III randomized trial of docetaxel-estramustine in high-risk localized prostate cancer: clinical design and current status. [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-153, 2006.

Trial Contact Information

Trial Lead Organizations

Federation Nationale des Centres de Lutte Contre le Cancer

Karim Fizazi, MD, PhD, Protocol chair
Ph: 33-1-4211-6264
Email: fizazi@igr.fr

Trial Sites

France
  Angers
 Centre Paul Papin
 Remy Delva
Ph: 33-49-800-918-507
  Bordeaux
 Hopital Saint Andre
 Alain Ravaud, MD, PhD
Ph: 33-5-5679-5808
 Email: alain.ravaud@chu-bordeaux.fr
 Institut Bergonie
 Nadine Houede
Ph: 33-556-333-333
 Email: houede@bergonie.org
  Boulogne-Billancourt
 Hopital Ambroise Pare
 Philippe Dalivoust
Ph: 33-4-9183-3741
  Caen
 Centre Regional Francois Baclesse
 Francois Lesaunier, MD
Ph: 33-231-455-050
 Email: f.lesaunier@baclesse.fr
  Cholet
 Polyclinique du Parc
 Alain Zanetti
Ph: 33-2-4163-4200
  Creteil
 Centre Hospitalier Universitaire Henri Mondor
 Jean-Leon Lagrange, MD
Ph: 33-1-49-814-524
 Email: jean-leon.lagrange@hmn.aphp.fr
  Hyeres
 Clinique Sainte-Marguerite
 Jean Berdah, MD
Ph: 33-4-9412-5555
 Email: jf.berdah@wanadoo.fr
  La Roche Sur Yon
 Centre Hospitalier Departemental
 Franck Priou, MD
Ph: 33-2-5144-6161
 Email: frank.priou@chd-vendee.fr
  Lille
 Centre Hospital Universitaire Hop Huriez
 Arnaud Villers, MD
Ph: 33-3-2044-4235
 Email: a-villers@chru.fr
  Limoges
 Centre Hospital Regional Universitaire de Limoges
 Jean-Luc Labourey
Ph: 33-5-5505-6123
  Lormont
 Polyclinique des Quatre Pavillons
 Pierre Guichard, MD
Ph: 33-5-5780-8489
  Lyon
 Centre Leon Berard
 Aude Flechon
Ph: 33-4-78-78-26-45
  Marseille
 CHU de la Timone
 Marjorie Baciuchka-Palmaro
Ph: 33-91-385-708
 Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
 Gwenaelle Gravis, MD
Ph: 33-4-9122-3740
 Email: gravisg@marseille.fnclcc.fr
  Metz
 Hopital Clinique Claude Bernard
 Louis-Marie Dourthe
Ph: 33-87-396-666
 Hopital Notre-Dame de Bon Secours
 Augustin Salemkour, MD
Ph: 33-3-3730-3270
  Mont-de-Marsan
 Centre Hospitalier General de Mont de Marsan
 Jerome Dauba
Ph: 33-5-5805-1725
  Montpellier
 Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
 Stephane Culine, MD
Ph: 33-4-6761-3755
 Email: stculine@valdorel.fnclcc.fr
 Hopital Lapeyronie-CHU Montpellier
 Eric Legouffe, MD
Ph: 33-4-67-33-80-79
 Email: e-legouffe@chu-montpellier.fr
  Nantes
 Centre Catherine de Sienne
 Claude El Kouri
Ph: 33-2-2827-2166
  Nantes-Saint Herblain
 CRLCC Nantes - Atlantique
 Frederic Rolland, MD
Ph: 33-2-40-67-99-76
 Email: F-rolland@nantes.fnclcc.fr
  Nice
 Centre Antoine Lacassagne
 Jean Marc Ferrero, MD
Ph: 33-4-9203-1114
 Email: jean-marc.ferrerero@nice.fnclcc.fr
  Paris
 Hopital de la Croix St. Simon
 Paul-Henri Cottu
Ph: 33-1-4474-1039
 Hopital Europeen Georges Pompidou
 Stephane Oudard, MD, PhD
Ph: 33-1-56-093-476
 Email: stephane.oudard@hop.egp.ap-hop-paris.fr
 Hopital Saint Joseph
 Gael Deplanque, MD, MSC, PhD
Ph: 33-1-4412-7626
 Email: gdeplanque@hpsj.fr
 Hopital Tenon
 Bernard Gattegno
Ph: 33-1-5601-6522
 Email: bernard.gattegno@tnn.aphp.fz
 Institut Curie Hopital
 Philippe Beuzeboc, MD
Ph: 33-44-32-4682
  Reims
 Institut Jean Godinot
 Jean-Christophe Eymard, MD
Ph: 33-03-2650-4444
 Email: jc.eymard@reims.fnclcc.fr
  Rennes
 Centre Eugene Marquis
 Pierre Kerbrat, MD, PhD
Ph: 33-299-253-280
 Email: kerbrat@rennes.fnclcc.fr
  Rodez
 Centre Hospitalier de Rodez
 Laurent Mosser
Ph: 33-05-6575-1212
  Rouen
 Centre Henri Becquerel
 Paule Chinet-Charrot
Ph: 33-2-3208-2222
  Saint Cloud
 Centre Rene Huguenin
 Alain Goupil
Ph: 33-1-47-111-515
  Suresnes
 Hopital Foch
 Laurence Le Moal
Ph: 33-1-4625-2168
  Toulouse
 Institut Claudius Regaud
 Christine Chevreau-Dalbianco, MD
Ph: 33-56-142-4114
 Email: chevreau@icr.fnclcc.fr
  Tours
 Centre Hospitalier Universitaire Bretonneau de Tours
 Claude Linassier, MD, PhD
Ph: 33-2-4747-8074
 Email: linassier@med.univ_tours.fr
  Vandoeuvre-les-Nancy
 Centre Alexis Vautrin
 Ivan Krakowski, MD
Ph: 33-83-598-486
 Email: i.krakowski@nancy.fnclcc.fr
  Villejuif
 Institut Gustave Roussy
 Karim Fizazi, MD, PhD
Ph: 33-1-4211-6264
 Email: fizazi@igr.fr

Registry Information
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
Trial Start Date 2002-11-01
Registered in ClinicalTrials.gov NCT00055731
Date Submitted to PDQ 2003-01-14
Information Last Verified 2008-04-27

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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