RATIONALE: Drugs used in chemotherapy use different ways to make cancer cells stop dividing so they stop growing or die. Combining chemotherapy with corticosteroids may be an effective treatment for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of methylprednisolone with or without doxorubicin in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Condition	Treatment or Intervention	Phase
stage IV prostate cancer recurrent prostate cancer	Procedure: chemotherapy  Procedure: hormone therapy  Procedure: steroid therapy  Procedure: endocrine therapy  Drug: doxorubicin  Drug: methylprednisolone	Phase III

Further Study Details: 

OBJECTIVES: I. Determine the effect of weekly doxorubicin on the quality of life of patients with metastatic, hormone-refractory, symptomatic prostate cancer. II. Determine the contribution of this treatment on control of pain in these patients. III. Determine the toxicity of this regimen in these patients. IV. Determine the objective response and biological observations in these patients after this treatment. V. Determine the effect of this regimen on survival of these patients.

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive methylprednisolone IV weekly for 3 months. Arm II: Patients receive methylprednisolone IV and doxorubicin IV weekly for 3 months. Quality of life is assessed before treatment, every 4 weeks during treatment, and then every 3 months. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study within 3 years.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven, symptomatic prostate cancer; Appearance or aggravation of clinical symptoms with progression of disease; Bone pain OR Urethral compression OR 20% decrease in performance status
• Metastatic disease; Local-regional or distant secondary tumors; Documented radiologically or scintigraphically
• Hormone-refractory as defined by progression while on hormone treatment (simple castration or complete androgen blockage)
• Progressive disease; No urethral or cervical stenosis; Increase of greater than 25% prostatic volume on endorectal echography; No documentation by PSA increase or imagery only
• Hormone castration verified by testosterone less than 0.5 ng/mL
• No history of CNS metastases

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemotherapy; Arm I: No concurrent chemotherapy
• Endocrine therapy: At least 1 month since prior hormone therapy, including estramustine, except LHRH agonists, which continue; Arm I: No concurrent estramustine
• Radiotherapy: At least 3 months since prior strontium 89; No concurrent strontium
• Surgery: See Disease Characteristics

--Patient Characteristics--

• Age: Over 18
• Performance status: Karnofsky 60-100%
• Life expectancy: No specified
• Hematopoietic: Neutrophil count greater than 1500/mm3; Platelet count greater than 100,000/mm3; Hemoglobin greater than 9 g/dL
• Hepatic: Bilirubin less than 1.5 times normal
• Renal: Creatinine less than 1.6 mg/dL
• Cardiovascular: Ventricular ejection fraction at least 50%
• Other: No contraindication to anthracycline treatment; No prior primary cancer except basal cell skin cancer

France
      C.H.U. - Hopital Gaston Doumergue, Nimes,  30006,  France
      Centre Antoine Lacassagne, Nice,  06189,  France
      Centre de Lute Contre le Cancer,Georges-Francois Leclerc, Dijon,  21079,  France
      Centre Eugene Marquis, Rennes,  35064,  France
      Centre Henri Becquerel, Rouen,  76038,  France
      Centre Hospitalier General de Saint Nazaire, Saint-Nazaire,  44600,  France
      Centre Leon Berard, Lyon,  69373,  France
      Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier,  34298,  France
      Centre Rene Huguenin, Saint Cloud,  92211,  France
      CRLCC Nantes - Atlantique, Nantes-Saint Herblain,  44805,  France
      Hotel Dieu de Paris, Paris,  75181,  France
      Institut J. Paoli and I. Calmettes, Marseille,  13273,  France
      Institut Jean Godinot, Reims,  51056,  France
      Institut Mutualiste Montsouris, Paris,  75013,  France
      Institut Sainte Catherine, Avignon,  84082,  France

Study chairs or principal investigators

Stephane Culine,  Study Chair,  Federation Nationale des Centres de Lutte Contre le Cancer   

Study ID Numbers:  CDR0000066784; FRE-FNCLCC-GETUG-02; EU-98058
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003682
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08