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Status:

COMPLETED

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

Lead Sponsor:

UNICANCER

Conditions:

Prostate Cancer

Eligibility:

MALE

18-120 years

Phase:

PHASE3

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 ...

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 progressi...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    October 18 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 15 2015

    Estimated Enrollment :

    385 Patients enrolled

    Trial Details

    Trial ID

    NCT00104715

    Start Date

    October 18 2004

    End Date

    December 15 2015

    Last Update

    February 21 2021

    Active Locations (41)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 11 (41 locations)

    1

    Centre Paul Papin

    Angers, France, 49100

    2

    Centre Hospitalier de la Cote Basque

    Bayonne, France, 64100

    3

    Hopital Avicenne

    Bobigny, France, 93009

    4

    Hopital Saint Andre

    Bordeaux, France, 33075