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

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

Outcomes

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.

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

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

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