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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00104715
Recruitment Status : Unknown
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : March 4, 2005
Last Update Posted : November 9, 2010
Sponsor:
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: antiandrogen therapy Drug: docetaxel Drug: goserelin acetate Procedure: orchiectomy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 378 participants
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
Study Start Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Docetaxel




Primary Outcome Measures :
  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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00104715


Locations
Show Show 41 study locations
Sponsors and Collaborators
UNICANCER
Investigators
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Study Chair: Gwenaelle Gravis, MD Institut Paoli-Calmettes

Publications of Results:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00104715    
Other Study ID Numbers: CDR0000416096
FRE-FNCLCC-GETUG-15/0403
EU-20505
First Posted: March 4, 2005    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: April 2008
Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Goserelin
Androgen Antagonists
Antineoplastic Agents
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