Hormone Therapy and Docetaxel or Hormone Therapy Alone in Treating Patients With Metastatic Prostate Cancer

NCT00104715 | Completed Phase 3 DMC

• 3 other identifiers: UC-0160/0403FRE-FNCLCC-GETUG-15/0403EU-20505
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 41

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Hormonotherapy + chemotherapy

EXPERIMENTAL

Drug: antiandrogen therapy; Drug: docetaxel; Drug: goserelin acetate; Procedure: orchiectomy

Hormonotherapy alone

ACTIVE COMPARATOR

Drug: antiandrogen therapy; Drug: goserelin acetate; Procedure: orchiectomy

Interventions

antiandrogen therapy DRUG

Hormonotherapy + chemotherapy; Hormonotherapy alone

docetaxel DRUG

Hormonotherapy + chemotherapy

goserelin acetate DRUG

Hormonotherapy + chemotherapy; Hormonotherapy alone

orchiectomy PROCEDURE

Hormonotherapy + chemotherapy; Hormonotherapy alone

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (41)

Centre Paul Papin

Angers, 49100, France

Location

Centre Hospitalier de la Cote Basque

Bayonne, 64100, France

Location

Hopital Avicenne

Bobigny, 93009, France

Location

Hopital Saint Andre

Bordeaux, 33075, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Polyclinique du Parc

Cholet, 49300, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94000, France

Location

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Location

Clinique Sainte-Marguerite

Hyères, 83400, France

Location

Centre Hospitalier Departemental

La Roche-sur-Yon, 85025, France

Location

Centre Hospitalier General

Le Mans, 72037, France

Location

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

Polyclinique des Quatre Pavillons

Lormont, 33310, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Hopital Notre-Dame de Bon Secours

Metz, 57038, France

Location

Centre Hospitalier General de Mont de Marsan

Mont-de-Marsan, 40000, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Clinique D'Occitanie

Muret, 31600, France

Location

Centre Catherine de Sienne

Nantes, 02, France

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau

Nîmes, 30029, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Institut Curie Hopital

Paris, 75248, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

Hopital Saint Joseph

Paris, 75674, France

Location

Hopital Tenon

Paris, 75970, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Centre Rene Huguenin

Saint-Cloud, 92211, France

Location

Hopital Foch

Suresnes, 92151, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Centre Hospitalier Regional de Purpan

Toulouse, 31059, France

Location

Clinique Du Parc

Toulouse, 31078, France

Location

Centre Hospitalier Universitaire Bretonneau de Tours

Tours, 37044, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Centre Hospitalier Regionale de Vichy

Vichy, 03201, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Related Publications (6)

• 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.

  RESULT

• 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.

  PMID: 25592642 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.

  PMID: 24210084 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.

  PMID: 23306100 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.

  PMID: 22747660 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists; Docetaxel; Goserelin; Orchiectomy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Castration; Endocrine Surgical Procedures; Surgical Procedures, Operative; Urogenital Surgical Procedures; Urologic Surgical Procedures, Male; Urologic Surgical Procedures

Study Officials

• Gwenaelle Gravis, MD

  Institut Paoli-Calmettes

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2005
• First Posted: March 4, 2005
• Study Start: October 18, 2004
• Primary Completion: December 4, 2011
• Study Completion: December 15, 2015
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

FR (41)