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| ID | Type | Description | Link |
|---|---|---|---|
| FRE-FNCLCC-GETUG-15/0403 | |||
| EU-20505 |
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RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with docetaxel may be an effective treatment for prostate cancer. It is not yet known whether giving hormone therapy together with docetaxel is more effective than hormone therapy alone in treating prostate cancer.
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.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 378 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hormonotherapy + chemotherapy | Experimental |
| |
| Hormonotherapy alone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antiandrogen therapy | Drug |
| ||
| docetaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival at 36 months | ||
| Progression-free survival (biological progression and/or clinical progression) at 24 months | ||
| Quality of life | ||
| Treatment costs | ||
| Toxicity and tolerance | ||
| Tumor profiles of gene expression as measured by biochips with DNA and tissue microarrays |
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DISEASE CHARACTERISTICS:
Histologically confirmed prostate adenocarcinoma
Measurable or evaluable disease
No brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No prior chemotherapy for metastatic prostate cancer
Prior chemotherapy allowed provided all of the following are true:
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Gwenaelle Gravis, MD | Institut Paoli-Calmettes | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Paul Papin | Angers | 49100 | France | |||
| Centre Hospitalier de la Cote Basque |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| Result | 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. | ||
| 25592642 | Derived | 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. |
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| Drug |
|
| goserelin acetate | Drug |
|
| orchiectomy | Procedure |
|
| Bayonne |
| 64100 |
| France |
| Hopital Avicenne | Bobigny | 93009 | France |
| Hopital Saint Andre | Bordeaux | 33075 | France |
| Institut Bergonie | Bordeaux | 33076 | France |
| Centre Regional Francois Baclesse | Caen | 14076 | France |
| Polyclinique du Parc | Cholet | 49300 | France |
| Centre Hospitalier Universitaire Henri Mondor | Créteil | 94000 | France |
| Centre de Lutte Contre le Cancer Georges-Francois Leclerc | Dijon | 21079 | France |
| Clinique Sainte-Marguerite | Hyères | 83400 | France |
| Centre Hospitalier Departemental | La Roche-sur-Yon | 85025 | France |
| Centre Hospitalier General | Le Mans | 72037 | France |
| Centre Hospital Regional Universitaire de Limoges | Limoges | 87042 | France |
| Polyclinique des Quatre Pavillons | Lormont | 33310 | France |
| Centre Leon Berard | Lyon | 69008 | France |
| Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes | Marseille | 13273 | France |
| CHU de la Timone | Marseille | 13385 | France |
| Hopital Notre-Dame de Bon Secours | Metz | 57038 | France |
| Centre Hospitalier General de Mont de Marsan | Mont-de-Marsan | 40000 | France |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Montpellier | 34298 | France |
| Clinique D'Occitanie | Muret | 31600 | France |
| Centre Catherine de Sienne | Nantes | 02 | France |
| CRLCC Nantes - Atlantique | Nantes-Saint Herblain | 44805 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau | Nîmes | 30029 | France |
| Hopital Europeen Georges Pompidou | Paris | 75015 | France |
| Institut Curie Hopital | Paris | 75248 | France |
| Hopital Saint-Louis | Paris | 75475 | France |
| Hopital Saint Joseph | Paris | 75674 | France |
| Hopital Tenon | Paris | 75970 | France |
| Institut Jean Godinot | Reims | 51056 | France |
| Centre Eugene Marquis | Rennes | 35042 | France |
| Centre Rene Huguenin | Saint-Cloud | 92211 | France |
| Hopital Foch | Suresnes | 92151 | France |
| Institut Claudius Regaud | Toulouse | 31052 | France |
| Centre Hospitalier Regional de Purpan | Toulouse | 31059 | France |
| Clinique Du Parc | Toulouse | 31078 | France |
| Centre Hospitalier Universitaire Bretonneau de Tours | Tours | 37044 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France |
| Centre Hospitalier Regionale de Vichy | Vichy | 03201 | France |
| Institut Gustave Roussy | Villejuif | F-94805 | France |
| 24210084 | Derived | 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. |
| 23306100 | Derived | 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. |
| 22747660 | Derived | 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. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000726 | Androgen Antagonists |
| D000077143 | Docetaxel |
| D017273 | Goserelin |
| D009919 | Orchiectomy |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D002369 | Castration |
| D013507 | Endocrine Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013519 | Urogenital Surgical Procedures |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
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