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CompletedNCT00104715Updated Feb 21, 2021

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

A Phase 3 interventional study of antiandrogen therapy and docetaxel in Prostate Cancer, sponsored by UNICANCER. Completed at 41 sites in France. Open to male participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2021-02-21.

Sponsored by UNICANCER · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Oct 2004, registered Mar 2005).
Phase
Phase 3
Study type
Interventional
Enrollment
385
Allocation
Randomized
Ages
18 Years to 120 Years
Sex
Male
01

Study 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.

Read the detailed description

OBJECTIVES:

  • 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage IV prostate cancer
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In context

Prostatic Neoplasms

6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.

This study's enrollment of 385 is above the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

UNICANCER is the lead sponsor of 215 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
385 participants (actual)

Study arms

  • Experimental
    Hormonotherapy + chemotherapy

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

  • Active comparator
    Hormonotherapy alone

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

Interventions

  • Drugantiandrogen therapy
  • Drugdocetaxel
  • Druggoserelin acetate
  • Procedureorchiectomy
06

What researchers measure

Primary outcomes

  1. Overall survival at 36 months

  2. Progression-free survival (biological progression and/or clinical progression) at 24 months

  3. Quality of life

  4. Treatment costs

  5. Toxicity and tolerance

  6. Tumor profiles of gene expression as measured by biochips with DNA and tissue microarrays

07

Study locations

41 sites
  • Centre Paul Papin
    Angers, 49100, France
  • Centre Hospitalier de la Cote Basque
    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
    Creteil, 94000, France
  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
    Dijon, 21079, France
  • Clinique Sainte-Marguerite
    Hyeres, 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
  • CRLCC Nantes - Atlantique
    Nantes-Saint Herblain, 44805, France
  • Centre Catherine de Sienne
    Nantes, 02, France
  • Centre Antoine Lacassagne
    Nice, 06189, France
  • C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
    Nimes, 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
    Vandoeuvre-les-Nancy, 54511, France
  • Centre Hospitalier Regionale de Vichy
    Vichy, 03201, France
  • Institut Gustave Roussy
    Villejuif, F-94805, France
08

References and documents

Publications

  • 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. PubMed 25592642 ↗
  • 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. PubMed 24210084 ↗
  • 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. PubMed 23306100 ↗
  • 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. PubMed 22747660 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00104715
Lead sponsor
UNICANCER
Responsible party
Sponsor
First posted
Mar 4, 2005
Start date
Oct 18, 2004
Primary completion
Dec 4, 2011
Completion
Dec 15, 2015
Last update
Feb 21, 2021

Study contacts

Gwenaelle Gravis, MD
study chair · Institut Paoli-Calmettes

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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