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Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse

Sponsor
UNICANCER (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00055731
Collaborator
Sanofi (Industry), AstraZeneca (Industry)
413
Enrollment
38
Locations
2
Arms
240.6
Anticipated Duration (Months)
10.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective with or without chemotherapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with or without docetaxel and estramustine in treating patients who have prostate cancer that is locally advanced or at high risk of relapse.

Condition or Disease Intervention/Treatment Phase
  • Drug: bicalutamide
  • Drug: Goserelin Acetate
  • Drug: docetaxel
  • Drug: Estramustine phosphate sodium
  • Drug: acetylsalicylic acid
  • Procedure: conventional surgery
  • Radiation: radiation therapy
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
413 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase III Randomized Study Of Adjuvant Hormonal Therapy With And Without Docetaxel And Estramustine In Patients With Advanced Prostate Cancer Or With A High Risk Of Relapse
Actual Study Start Date :
Nov 14, 2002
Actual Primary Completion Date :
Dec 21, 2010
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Chemotherapy

Drug: bicalutamide
Other Names:
  • CASODEX®

    • Drug: Goserelin Acetate
    Other Names:
  • ZOLADEX®

    • Drug: docetaxel

    Drug: Estramustine phosphate sodium

    Drug: acetylsalicylic acid
    Other Names:
  • Aspirin

    • Procedure: conventional surgery

    Radiation: radiation therapy
    Active Comparator: Without Chemotherapy

    Drug: bicalutamide
    Other Names:
  • CASODEX®

    • Drug: Goserelin Acetate
    Other Names:
  • ZOLADEX®

    • Procedure: conventional surgery

    Radiation: radiation therapy

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival [From randomization to disease progression or death, up to 15 years.]

      The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.

    2. Biological response: Prostate-specific antigen (PSA) level [3 months]

      The biological response is defined as a non-detectable serum PSA level (<0.1 ng/ml)

    3. Cancer progression as measured by ultrasound [From randomization to disease progression, up to 15 years.]

      Defined as a decrease of at least 20% in prostate volume detected by ultrasound after the neo-adjuvant treatment

    4. Clinical progression-free survival [From randomization to disease progression or death, up to 15 years.]

      The clinical progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse (based on bone scintigraphy, pelvic scan, or MRI evaluation).

    5. Overall survival [From randomization to death from any cause, up to 15 years.]

      The overall survival is the length of time from randomization that patients enrolled in the study are still alive. The outcome is to evaluate whether SRBT improves overall survival compared to standard of care.

    6. Acute and late toxicity during the study [Throughout study completion, up to 15 years.]

      The National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.

    7. Quality of life questionnaire - Core 30 (QLQ-C30) [At baseline, 3 months, and 1 year]

      Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years to 79 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically confirmed adenocarcinoma of the prostate

    • Locally advanced disease or at high risk for relapse

    • No clinically or radiologically suspected metastases

    • Prior lymphadenectomy required

    • Meets at least 1 of the following criteria for poor prognosis:

    • Gleason score greater than 7

    • T3 or T4 disease

    • Prostate-specific antigen greater than 20 ng/mL

    • N1 disease

    PATIENT CHARACTERISTICS:

    Age

    • Under 80

    Performance status

    • ECOG 0-2

    Life expectancy

    • More than 10 years

    Hematopoietic

    • Absolute neutrophil count greater than 1,500/mm^3

    • Platelet count at least 100,000/mm^3

    Hepatic

    • AST and ALT no greater than 1.5 times upper limit of normal (ULN)

    • Bilirubin no greater than ULN

    Renal

    • Creatinine less than 1.6 mg/dL OR

    • Creatinine clearance greater than 60 mL/min

    Cardiovascular

    • No uncontrolled or severe cardiovascular disease

    • No prior thrombosis

    Pulmonary

    • No prior pulmonary embolus

    Other

    • No active infection

    • No intolerance to aspirin

    • No other prior malignancy except basal cell skin cancer

    • No physical or psychological condition that would preclude study compliance

    PRIOR CONCURRENT THERAPY:

    Biologic therapy

    • No concurrent immunotherapy

    Chemotherapy

    • No prior chemotherapy

    • No other concurrent chemotherapy

    Endocrine therapy

    • No prior hormonal therapy

    • No other concurrent hormonal therapy

    Radiotherapy

    • Not specified

    Surgery

    • See Disease Characteristics

    Other

    • No other concurrent anticancer therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Paul Papin Angers France 49100
    2 Hopital Saint Andre Bordeaux France 33075
    3 Institut Bergonie Bordeaux France 33076
    4 Hopital Ambroise Pare Boulogne-Billancourt France F-92104
    5 Centre Regional Francois Baclesse Caen France 14076
    6 Polyclinique du Parc Cholet France 49300
    7 Centre Hospitalier Universitaire Henri Mondor Creteil France 94000
    8 Clinique Sainte-Marguerite Hyeres France 83400
    9 Centre Hospitalier Departemental La Roche Sur Yon France 85025
    10 Centre Hospital Universitaire Hop Huriez Lille France 59037
    11 Centre Hospital Regional Universitaire de Limoges Limoges France 87042
    12 Polyclinique des Quatre Pavillons Lormont France 33310
    13 Centre Leon Berard Lyon France 69008
    14 Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes Marseille France 13273
    15 CHU de la Timone Marseille France 13385
    16 Hopital Notre-Dame de Bon Secours Metz France 57038
    17 Hopital Clinique Claude Bernard Metz France 57072
    18 Centre Hospitalier General de Mont de Marsan Mont-de-Marsan France 40000
    19 Hopital Lapeyronie-CHU Montpellier Montpellier France 34295
    20 Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Montpellier France 34298
    21 Centre Catherine de Sienne Nantes France 02
    22 Centre Antoine Lacassagne Nice France 06189
    23 Hopital Europeen Georges Pompidou Paris France 75015
    24 Hopital de la Croix St. Simon Paris France 75020
    25 Institut Curie Hopital Paris France 75248
    26 Hopital Saint Joseph Paris France 75674
    27 Hopital Tenon Paris France 75970
    28 Institut Jean Godinot Reims France 51056
    29 Centre Eugene Marquis Rennes France 35042
    30 Centre Hospitalier de Rodez Rodez France 12027
    31 Centre Henri Becquerel Rouen France 76038
    32 Centre Rene Huguenin Saint Cloud France 92211
    33 CRLCC Nantes - Atlantique Saint-Herblain France 44805
    34 Hopital Foch Suresnes France 92151
    35 Institut Claudius Regaud Toulouse France 31052
    36 Centre Hospitalier Universitaire Bretonneau de Tours Tours France 37044
    37 Centre Alexis Vautrin Vandoeuvre-les-Nancy France 54511
    38 Institut Gustave Roussy Villejuif France F-94805

    Sponsors and Collaborators

    • UNICANCER
    • Sanofi
    • AstraZeneca

    Investigators

    • Study Chair: Karim Fizazi, MD, PhD, Gustave Roussy, Cancer Campus, Grand Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    UNICANCER
    ClinicalTrials.gov Identifier:
    NCT00055731
    Other Study ID Numbers:
    • GETUG-12 - UC-0160/0203
    • CDR0000270970
    • EU-20238
    First Posted:
    Mar 7, 2003
    Last Update Posted:
    Mar 8, 2022
    Last Verified:
    Feb 1, 2022
    Keywords provided by UNICANCER
    stage III prostate cancer
    stage IIB prostate cancer
    stage IIA prostate cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Aspirin
    Docetaxel
    Goserelin
    Bicalutamide
    Estramustine

    Study Results

    No Results Posted as of Mar 8, 2022