Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse
NCT ID: NCT00055731
Last Updated: 2023-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
413 participants
INTERVENTIONAL
2002-11-14
2022-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemotherapy
bicalutamide
Goserelin Acetate
docetaxel
Estramustine phosphate sodium
acetylsalicylic acid
conventional surgery
radiation therapy
Without Chemotherapy
bicalutamide
Goserelin Acetate
conventional surgery
radiation therapy
Interventions
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bicalutamide
Goserelin Acetate
docetaxel
Estramustine phosphate sodium
acetylsalicylic acid
conventional surgery
radiation therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
PATIENT CHARACTERISTICS:
Age
* Under 80
Performance status
* ECOG 0-2
Life expectancy
* More than 10 years
Hematopoietic
* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
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
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
0 Years
79 Years
MALE
No
Sponsors
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Sanofi
INDUSTRY
AstraZeneca
INDUSTRY
UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Karim Fizazi, MD, PhD
Role: STUDY_CHAIR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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Centre Paul Papin
Angers, , France
Hopital Saint Andre
Bordeaux, , France
Institut Bergonie
Bordeaux, , France
Hopital Ambroise Pare
Boulogne-Billancourt, , France
Centre Regional Francois Baclesse
Caen, , France
Polyclinique du Parc
Cholet, , France
Centre Hospitalier Universitaire Henri Mondor
Créteil, , France
Clinique Sainte-Marguerite
Hyères, , France
Centre Hospitalier Departemental
La Roche-sur-Yon, , France
Centre Hospital Universitaire Hop Huriez
Lille, , France
Centre Hospital Regional Universitaire de Limoges
Limoges, , France
Polyclinique des Quatre Pavillons
Lormont, , France
Centre Leon Berard
Lyon, , France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, , France
CHU de la Timone
Marseille, , France
Hopital Notre-Dame de Bon Secours
Metz, , France
Hopital Clinique Claude Bernard
Metz, , France
Centre Hospitalier General de Mont de Marsan
Mont-de-Marsan, , France
Hopital Lapeyronie-CHU Montpellier
Montpellier, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
Centre Catherine de Sienne
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
Hopital Europeen Georges Pompidou
Paris, , France
Hopital de la Croix St. Simon
Paris, , France
Institut Curie Hopital
Paris, , France
Hopital Saint Joseph
Paris, , France
Hopital Tenon
Paris, , France
Institut Jean Godinot
Reims, , France
Centre Eugene Marquis
Rennes, , France
Centre Hospitalier de Rodez
Rodez, , France
Centre Henri Becquerel
Rouen, , France
Centre Rene Huguenin
Saint-Cloud, , France
CRLCC Nantes - Atlantique
Saint-Herblain, , France
Hopital Foch
Suresnes, , France
Institut Claudius Regaud
Toulouse, , France
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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Fizazi K, Lesaunier F, Delva R, Gravis G, Rolland F, Priou F, Ferrero JM, Houede N, Mourey L, Theodore C, Krakowski I, Berdah JF, Baciuchka M, Laguerre B, Flechon A, Ravaud A, Cojean-Zelek I, Oudard S, Labourey JL, Lagrange JL, Chinet-Charrot P, Linassier C, Deplanque G, Beuzeboc P, Geneve J, Davin JL, Tournay E, Culine S. A phase III trial of docetaxel-estramustine in high-risk localised prostate cancer: a planned analysis of response, toxicity and quality of life in the GETUG 12 trial. Eur J Cancer. 2012 Jan;48(2):209-17. doi: 10.1016/j.ejca.2011.10.015. Epub 2011 Nov 24.
Fizazi K, Lesaunier F, Delva R, et al.: A phase III trial of docetaxel-estramustine in high-risk localized prostate cancer (GETUG 12 trial): design, tolerance, response, and quality of life (QOL). [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-7, 2010.
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.
Fizazi K, Faivre L, Lesaunier F, Delva R, Gravis G, Rolland F, Priou F, Ferrero JM, Houede N, Mourey L, Theodore C, Krakowski I, Berdah JF, Baciuchka M, Laguerre B, Flechon A, Ravaud A, Cojean-Zelek I, Oudard S, Labourey JL, Chinet-Charrot P, Legouffe E, Lagrange JL, Linassier C, Deplanque G, Beuzeboc P, Davin JL, Martin AL, Habibian M, Laplanche A, Culine S. Androgen deprivation therapy plus docetaxel and estramustine versus androgen deprivation therapy alone for high-risk localised prostate cancer (GETUG 12): a phase 3 randomised controlled trial. Lancet Oncol. 2015 Jul;16(7):787-94. doi: 10.1016/S1470-2045(15)00011-X. Epub 2015 May 28.
Other Identifiers
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CDR0000270970
Identifier Type: -
Identifier Source: secondary_id
EU-20238
Identifier Type: -
Identifier Source: secondary_id
GETUG-12 - UC-0160/0203
Identifier Type: -
Identifier Source: org_study_id
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