Hormone Therapy Compared With Combination Chemotherapy in Treating Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as
      ketoconazole may stop the production of 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 than combination chemotherapy in treating prostate
      cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with that
      of combination chemotherapy in treating patients who have prostate cancer that has been
      previously treated with androgen suppression.
    

Detailed description: 
      OBJECTIVES:

        -  Compare time to objective progression in patients with prostate cancer and a rising
           prostate-specific antigen (PSA) after androgen suppression when treated with second-line
           hormonal therapy (ketoconazole and hydrocortisone) vs combination chemotherapy
           (docetaxel and estramustine).

        -  Compare time to PSA progression and correlate this with time to objective progression in
           patients treated with these regimens.

        -  Compare the quality of life in patients treated with these regimens.

        -  Compare overall survival of patients treated with these regimens.

        -  Compare the natural history of progression in patients treated with these regimens.

        -  Identify prognostic indicators of clinical outcome by immunohistochemical evaluation of
           apoptopic biomarkers in patients treated with these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
      treatment with bisphosphonates (yes vs no). Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive oral ketoconazole three times daily and oral hydrocortisone
           twice daily. Treatment continues in the absence of disease progression or unacceptable
           toxicity.

        -  Arm II: Patients receive oral estramustine three times daily on days 1-5 and docetaxel
           IV over 1 hour on day 2. Treatment repeats every 3 weeks for up to 6 courses in the
           absence of disease progression or unacceptable toxicity.

      Quality of life is assessed at baseline, on day 1 of week 9, at 6 months and 1 year, and then
      annually for up to 10 years or until beginning of first non-protocol therapy.

      Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
      annually for 5 years.

      PROJECTED ACCRUAL: A total of 590 patients (295 per treatment arm) will be accrued for this
      study within 4 years.
    

Intervention name(s): docetaxel; estramustine phosphate sodium; ketoconazole; therapeutic hydrocortisone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Ketoconazole; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Docetaxel; Estramustine
Allocation: Randomized
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; stage III prostate cancer