Hormone Therapy and Docetaxel or Hormone Therapy Alone in Treating Patients With Metastatic Prostate Cancer
NCT ID: NCT00104715
Last Updated: 2021-02-21
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
385 participants
INTERVENTIONAL
2004-10-18
2015-12-15
Brief Summary
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PURPOSE: This randomized phase III trial is studying hormone therapy and docetaxel to see how well they work compared to hormone therapy alone in treating patients with metastatic prostate cancer.
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Detailed Description
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* Compare 36-month overall survival of patients with metastatic prostate adenocarcinoma treated with hormonal therapy and docetaxel vs hormonal therapy alone.
* Compare 24-month progression-free survival (biological progression and/or clinical progression) in patients treated with these regimens.
* Compare the quality of life of patients treated with these regimens.
* Compare costs of these regimens for these patients.
* Compare the tolerability of these regimens in these patients.
* Compare the toxicity profile of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive hormonal therapy comprising 1 of the following: goserelin alone OR goserelin and antiandrogen therapy OR surgical castration. Hormonal therapy continues until the development of hormone resistance. Within 2 months after initiation of hormonal therapy, patients receive docetaxel IV every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive hormonal therapy as in arm I. Quality of life is assessed.
PROJECTED ACCRUAL: A total of 378 patients will be accrued for this study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hormonotherapy + chemotherapy
antiandrogen therapy
docetaxel
goserelin acetate
orchiectomy
Hormonotherapy alone
antiandrogen therapy
goserelin acetate
orchiectomy
Interventions
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antiandrogen therapy
docetaxel
goserelin acetate
orchiectomy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed prostate adenocarcinoma
* Metastatic disease
* Measurable or evaluable disease
* No brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 3 months
Hematopoietic
* WBC ≥ 2,000/mm\^3
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN) (2.5 times normal if hepatic metastases are present)
* AST and ALT ≤ 1.5 times ULN (2.5 times normal if hepatic metastases are present)
Renal
* Creatinine ≤ 150 μmol/L
Cardiovascular
* No symptomatic coronary disease
* No congenital cardiac insufficiency
* No New York Heart Association class III or IV cardiovascular disease
* No other severe cardiovascular disease
Other
* No severe peripheral neuropathy
* No active infection
* No other malignancy within the past 5 years except basal cell skin cancer
* No familial, social, geographical, or psychological situation that would preclude study compliance and follow-up
* No other serious disease that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for metastatic prostate cancer
* Prior chemotherapy allowed provided all of the following are true:
* Chemotherapy was completed \> 1 year ago
* Prostate-specific antigen level has remained stable
* No development of metastases within 1 year after completion of chemotherapy
Endocrine therapy
* Prior hormonal therapy within the past 2 months allowed for metastatic prostate cancer
Radiotherapy
* More than 4 weeks since prior radiotherapy to metastatic sites
Surgery
* No prior surgical castration
Other
* No other concurrent investigational drugs
18 Years
120 Years
MALE
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Gwenaelle Gravis, MD
Role: STUDY_CHAIR
Institut Paoli-Calmettes
Locations
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Centre Paul Papin
Angers, , France
Centre Hospitalier de la Cote Basque
Bayonne, , France
Hopital Avicenne
Bobigny, , France
Hopital Saint Andre
Bordeaux, , France
Institut Bergonie
Bordeaux, , France
Centre Regional Francois Baclesse
Caen, , France
Polyclinique du Parc
Cholet, , France
Centre Hospitalier Universitaire Henri Mondor
Créteil, , France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, , France
Clinique Sainte-Marguerite
Hyères, , France
Centre Hospitalier Departemental
La Roche-sur-Yon, , France
Centre Hospitalier General
Le Mans, , 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
Centre Hospitalier General de Mont de Marsan
Mont-de-Marsan, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
Clinique D'Occitanie
Muret, , France
Centre Catherine de Sienne
Nantes, , France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , France
Centre Antoine Lacassagne
Nice, , France
C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
Nîmes, , France
Hopital Europeen Georges Pompidou
Paris, , France
Institut Curie Hopital
Paris, , France
Hopital Saint-Louis
Paris, , France
Hopital Saint Joseph
Paris, , France
Hopital Tenon
Paris, , France
Institut Jean Godinot
Reims, , France
Centre Eugene Marquis
Rennes, , France
Centre Rene Huguenin
Saint-Cloud, , France
Hopital Foch
Suresnes, , France
Institut Claudius Regaud
Toulouse, , France
Centre Hospitalier Regional de Purpan
Toulouse, , France
Clinique Du Parc
Toulouse, , France
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Centre Hospitalier Regionale de Vichy
Vichy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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Gravis G, Fizazi K, Joly F, et al.: Safety results from a phase III trial comparing androgen-deprivation therapy (ADT) plus docetaxel versus ADT alone in hormone-naïve metastatic prostate cancer (GETUG-AFU 15/0403). [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-43, 2010.
Gravis G, Fizazi K, Joly F, et al.: Randomized phase III study comparing docetaxel and androgen deprivation therapy (ADT) versus ADT alone in androgen dependent metastatic prostate cancer (GETUG-15/0403): a French national muticentric study sponsored by the French Federation des Centres. [Abstract] American Society of Clinical Oncology 2007 Prostate Cancer Symposium, 22-24 February 2007, Orlando, FL. A-161, 2007.
Campillo-Gimenez B, Buscail C, Zekri O, Laguerre B, Le Prise E, De Crevoisier R, Cuggia M. Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials. Trials. 2015 Jan 16;16:15. doi: 10.1186/s13063-014-0535-7.
Trump DL. Commentary on "Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial." Gravis G, Fizazi K, Joly F, Oudard S, Priou F, Esterni B, Latorzeff I, Delva R, Krakowski I, Laguerre B, Rolland F, Theodore C, Deplanque G, Ferrero JM, Pouessel D, Mourey L, Beuzeboc P, Zanetta S, Habibian M, Berdah JF, Dauba J, Baciuchka M, Platini C, Linassier C, Labourey JL, Machiels JP, El Kouri C, Ravaud A, Suc E, Eymard JC, Hasbini A, Bousquet G, Soulie M, Medical Oncology and Biostatistics, Institut Paoli-Calmettes, Marseille, France. Lancet Oncol 2013;14(2):149-58 [Epub 2013 Jan 8]. Urol Oncol. 2013 Nov;31(8):1845. doi: 10.1016/j.urolonc.2013.08.011.
Gravis G, Fizazi K, Joly F, Oudard S, Priou F, Esterni B, Latorzeff I, Delva R, Krakowski I, Laguerre B, Rolland F, Theodore C, Deplanque G, Ferrero JM, Pouessel D, Mourey L, Beuzeboc P, Zanetta S, Habibian M, Berdah JF, Dauba J, Baciuchka M, Platini C, Linassier C, Labourey JL, Machiels JP, El Kouri C, Ravaud A, Suc E, Eymard JC, Hasbini A, Bousquet G, Soulie M. Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013 Feb;14(2):149-58. doi: 10.1016/S1470-2045(12)70560-0. Epub 2013 Jan 8.
Huang X, Chau CH, Figg WD. Challenges to improved therapeutics for metastatic castrate resistant prostate cancer: from recent successes and failures. J Hematol Oncol. 2012 Jul 2;5:35. doi: 10.1186/1756-8722-5-35.
Other Identifiers
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FRE-FNCLCC-GETUG-15/0403
Identifier Type: -
Identifier Source: secondary_id
EU-20505
Identifier Type: -
Identifier Source: secondary_id
UC-0160/0403
Identifier Type: -
Identifier Source: org_study_id
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