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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00104715
First received: March 3, 2005
Last updated: November 6, 2010
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: antiandrogen therapy
Drug: docetaxel
Drug: goserelin acetate
Procedure: orchiectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Phase III Trial Comparing an Association of Hormonal Treatment and Docetaxel Versus the Hormonal Treatment Alone in Metastatic Prostate Cancers

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival at 36 months [ Designated as safety issue: No ]
  • Progression-free survival (biological progression and/or clinical progression) at 24 months [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Treatment costs [ Designated as safety issue: No ]
  • Toxicity and tolerance [ Designated as safety issue: Yes ]
  • Tumor profiles of gene expression as measured by biochips with DNA and tissue microarrays [ Designated as safety issue: No ]

Estimated Enrollment: 378
Study Start Date: October 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104715

Locations
France
Centre Paul Papin
Angers, France, 49100
Centre Hospitalier de la Cote Basque
Bayonne, France, 64100
Hopital Avicenne
Bobigny, France, 93009
Hopital Saint Andre
Bordeaux, France, 33075
Institut Bergonie
Bordeaux, France, 33076
Centre Regional Francois Baclesse
Caen, France, 14076
Polyclinique du Parc
Cholet, France, 49300
Centre Hospitalier Universitaire Henri Mondor
Creteil, France, 94000
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, France, 21079
Clinique Sainte-Marguerite
Hyeres, France, 83400
Centre Hospitalier Departemental
La Roche Sur Yon, France, 85025
Centre Hospitalier General
Le Mans, France, 72037
Centre Hospital Regional Universitaire de Limoges
Limoges, France, 87042
Polyclinique des Quatre Pavillons
Lormont, France, 33310
Centre Leon Berard
Lyon, France, 69008
CHU de la Timone
Marseille, France, 13385
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Hopital Notre-Dame de Bon Secours
Metz, France, 57038
Centre Hospitalier General de Mont de Marsan
Mont-de-Marsan, France, 40000
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Clinique D'Occitanie
Muret, France, 31600
Centre Catherine de Sienne
Nantes, France, 02
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France, 44805
Centre Antoine Lacassagne
Nice, France, 06189
C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
Nimes, France, 30029
Hopital Tenon
Paris, France, 75970
Hopital Europeen Georges Pompidou
Paris, France, 75015
Hopital Saint Joseph
Paris, France, 75674
Institut Curie Hopital
Paris, France, 75248
Hopital Saint-Louis
Paris, France, 75475
Institut Jean Godinot
Reims, France, 51056
Centre Eugene Marquis
Rennes, France, 35042
Centre Rene Huguenin
Saint Cloud, France, 92211
Hopital Foch
Suresnes, France, 92151
Centre Hospitalier Regional de Purpan
Toulouse, France, 31059
Institut Claudius Regaud
Toulouse, France, 31052
Clinique Du Parc
Toulouse, France, 31078
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, France, 37044
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Centre Hospitalier Regionale de Vichy
Vichy, France, 03201
Institut Gustave Roussy
Villejuif, France, F-94805
Sponsors and Collaborators
UNICANCER
Investigators
Study Chair: Gwenaelle Gravis, MD Institut Paoli-Calmettes
  More Information

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00104715     History of Changes
Other Study ID Numbers: CDR0000416096, FRE-FNCLCC-GETUG-15/0403, EU-20505
Study First Received: March 3, 2005
Last Updated: November 6, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Goserelin
Androgen Antagonists
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014