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Sponsored by: |
Federation Nationale des Centres de Lutte Contre le Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00055731 |
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 |
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Prostate Cancer |
Drug: bicalutamide Drug: buserelin Drug: cyproterone acetate Drug: docetaxel Drug: estramustine phosphate sodium Drug: flutamide Drug: goserelin Drug: leuprolide acetate Drug: nilutamide Drug: triptorelin Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
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 |
Estimated Enrollment: | 250 |
Study Start Date: | November 2002 |
OBJECTIVES:
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.
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Meets at least 1 of the following criteria for poor prognosis:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
France | |
Centre Alexis Vautrin | Recruiting |
Vandoeuvre-les-Nancy, France, 54511 | |
Contact: Ivan Krakowski, MD 33-83-598-486 i.krakowski@nancy.fnclcc.fr | |
Centre Antoine Lacassagne | Recruiting |
Nice, France, 06189 | |
Contact: Jean Marc Ferrero, MD 33-4-9203-1114 jean-marc.ferrerero@nice.fnclcc.fr | |
Centre Catherine de Sienne | Recruiting |
Nantes, France, 02 | |
Contact: Claude El Kouri 33-2-2827-2166 | |
Centre Eugene Marquis | Recruiting |
Rennes, France, 35042 | |
Contact: Pierre Kerbrat, MD, PhD 33-299-253-280 kerbrat@rennes.fnclcc.fr | |
Centre Henri Becquerel | Recruiting |
Rouen, France, 76038 | |
Contact: Paule Chinet-Charrot 33-2-3208-2222 | |
Centre Hospital Regional Universitaire de Limoges | Recruiting |
Limoges, France, 87042 | |
Contact: Jean-Luc Labourey 33-5-5505-6123 | |
Centre Hospital Universitaire Hop Huriez | Recruiting |
Lille, France, 59037 | |
Contact: Arnaud Villers, MD 33-3-2044-4235 a-villers@chru.fr | |
Centre Hospitalier de Rodez | Recruiting |
Rodez, France, 12027 | |
Contact: Laurent Mosser 33-05-6575-1212 | |
Centre Hospitalier Departemental | Recruiting |
La Roche Sur Yon, France, 85025 | |
Contact: Franck Priou, MD 33-2-5144-6161 frank.priou@chd-vendee.fr | |
Centre Hospitalier General de Mont de Marsan | Recruiting |
Mont-de-Marsan, France, 40000 | |
Contact: Jerome Dauba 33-5-5805-1725 | |
Centre Hospitalier Universitaire Bretonneau de Tours | Recruiting |
Tours, France, 37044 | |
Contact: Claude Linassier, MD, PhD 33-2-4747-8074 linassier@med.univ_tours.fr | |
Centre Hospitalier Universitaire Henri Mondor | Recruiting |
Creteil, France, 94000 | |
Contact: Jean-Leon Lagrange, MD 33-1-49-814-524 jean-leon.lagrange@hmn.aphp.fr | |
Centre Leon Berard | Recruiting |
Lyon, France, 69008 | |
Contact: Aude Flechon 33-4-78-78-26-45 | |
Centre Paul Papin | Recruiting |
Angers, France, 49100 | |
Contact: Remy Delva 33-49-800-918-507 | |
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Recruiting |
Montpellier, France, 34298 | |
Contact: Stephane Culine, MD 33-4-6761-3755 stculine@valdorel.fnclcc.fr | |
Centre Regional Francois Baclesse | Recruiting |
Caen, France, 14076 | |
Contact: Francois Lesaunier, MD 33-231-455-050 f.lesaunier@baclesse.fr | |
Centre Rene Huguenin | Recruiting |
Saint Cloud, France, 92211 | |
Contact: Alain Goupil 33-1-47-111-515 | |
CHU de la Timone | Recruiting |
Marseille, France, 13385 | |
Contact: Marjorie Baciuchka-Palmaro 33-91-385-708 | |
Clinique Sainte-Marguerite | Recruiting |
Hyeres, France, 83400 | |
Contact: Jean F. Berdah, MD 33-4-9412-5555 jf.berdah@wanadoo.fr | |
Polyclinique du Parc | Recruiting |
Cholet, France, 49300 | |
Contact: Alain Zanetti 33-2-4163-4200 | |
Hopital Ambroise Pare | Recruiting |
Boulogne-Billancourt, France, F-92104 | |
Contact: Philippe Dalivoust 33-4-9183-3741 | |
Hopital Clinique Claude Bernard | Recruiting |
Metz, France, 57072 | |
Contact: Louis-Marie Dourthe 33-87-396-666 | |
Hopital de la Croix St. Simon | Recruiting |
Paris, France, 75020 | |
Contact: Paul-Henri Cottu 33-1-4474-1039 | |
Hopital Europeen Georges Pompidou | Recruiting |
Paris, France, 75015 | |
Contact: Stephane Oudard, MD, PhD 33-1-56-093-476 stephane.oudard@hop.egp.ap-hop-paris.fr | |
Hopital Foch | Recruiting |
Suresnes, France, 92151 | |
Contact: Laurence B. Le Moal 33-1-4625-2168 | |
Hopital Lapeyronie-CHU Montpellier | Recruiting |
Montpellier, France, 34295 | |
Contact: Eric Legouffe, MD 33-4-67-33-80-79 e-legouffe@chu-montpellier.fr | |
Hopital Notre-Dame de Bon Secours | Recruiting |
Metz, France, 57038 | |
Contact: Augustin Salemkour, MD 33-3-3730-3270 | |
Hopital Saint Andre | Recruiting |
Bordeaux, France, 33075 | |
Contact: Alain Ravaud, MD, PhD 33-5-5679-5808 alain.ravaud@chu-bordeaux.fr | |
Hopital Saint Joseph | Recruiting |
Paris, France, 75674 | |
Contact: Gael Deplanque, MD, MSC, PhD 33-1-4412-7626 gdeplanque@hpsj.fr | |
Hopital Tenon | Recruiting |
Paris, France, 75970 | |
Contact: Bernard Gattegno 33-1-5601-6522 bernard.gattegno@tnn.aphp.fz | |
Institut Bergonie | Recruiting |
Bordeaux, France, 33076 | |
Contact: Nadine Houede 33-556-333-333 houede@bergonie.org | |
Institut Claudius Regaud | Recruiting |
Toulouse, France, 31052 | |
Contact: Christine Chevreau-Dalbianco, MD 33-56-142-4114 chevreau@icr.fnclcc.fr | |
Institut Curie Hopital | Recruiting |
Paris, France, 75248 | |
Contact: Philippe Beuzeboc, MD 33-44-32-4682 | |
Institut Gustave Roussy | Recruiting |
Villejuif, France, F-94805 | |
Contact: Karim Fizazi, MD, PhD 33-1-4211-6264 fizazi@igr.fr | |
Institut Jean Godinot | Recruiting |
Reims, France, 51056 | |
Contact: Jean-Christophe Eymard, MD 33-03-2650-4444 jc.eymard@reims.fnclcc.fr | |
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes | Recruiting |
Marseille, France, 13273 | |
Contact: Gwenaelle Gravis, MD 33-4-9122-3740 gravisg@marseille.fnclcc.fr | |
Polyclinique des Quatre Pavillons | Recruiting |
Lormont, France, 33310 | |
Contact: Pierre Guichard, MD 33-5-5780-8489 | |
CRLCC Nantes - Atlantique | Recruiting |
Nantes-Saint Herblain, France, 44805 | |
Contact: Frederic Rolland, MD 33-2-40-67-99-76 F-rolland@nantes.fnclcc.fr |
Study Chair: | Karim Fizazi, MD, PhD | Institut Gustave Roussy |
Study ID Numbers: | CDR0000270970, FRE-FNCLCC-GETUG-12/0203, EU-20238 |
Study First Received: | March 6, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00055731 |
Health Authority: | Unspecified |
stage III prostate cancer stage II prostate cancer |
Buserelin Genital Neoplasms, Male Prostatic Diseases Nilutamide Cyproterone Acetate Estramustine Cyproterone Goserelin Urogenital Neoplasms |
Genital Diseases, Male Flutamide Docetaxel Leuprolide Triptorelin Bicalutamide Diane Prostatic Neoplasms |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Contraceptive Agents Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Luteolytic Agents |
Contraceptive Agents, Male Pharmacologic Actions Neoplasms Androgen Antagonists Neoplasms by Site Fertility Agents, Female Therapeutic Uses Fertility Agents Antineoplastic Agents, Alkylating Alkylating Agents |