S9921, Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy
      may fight prostate cancer by reducing 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 plus mitoxantrone and prednisone is more effective than
      hormone therapy alone for prostate cancer.

      PURPOSE: This randomized phase III trial is studying hormone therapy, mitoxantrone, and
      prednisone to see how well they work compared to hormone therapy alone in treating patients
      who have undergone radical prostatectomy for prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the overall and disease-free survival of patients with high-risk adenocarcinoma
           of the prostate treated with adjuvant androgen deprivation therapy with or without
           mitoxantrone and prednisone after radical prostatectomy.

        -  Compare the qualitative and quantitative toxic effects of these regimens in this patient
           population.

        -  Compare the prostate-specific antigen (PSA) progression-free survival rate in patient
           treated with these regimens.

        -  Determine whether PSA progression is a surrogate endpoint for survival or disease-free
           survival in this patient population.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      surgical extent of disease (organ confined vs not organ confined, but N0 vs N1), Gleason's
      sum (less than 7 vs 7 vs greater than 7), and planned radiotherapy (yes vs no). Patients are
      randomized to one of two treatment arms.

        -  Arm I:Patients receive goserelin subcutaneously once every 13 weeks (8 injections total)
           and oral bicalutamide once daily for 2 years in the absence of disease progression or
           unacceptable toxicity.

        -  Arm II:Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone
           twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence
           of disease progression or unacceptable toxicity. Patients also receive hormonal therapy
           as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone.

      Patients may undergo radiotherapy 5 days a week for 6.5-7.8 weeks beginning anytime (arm I)
      or after completion of chemotherapy (arm II), at the discretion of the physician, in the
      absence of disease progression or unacceptable toxicity.

      Patients are offered the possibility to participate in biomarker research by allowing their
      tissue/blood to be studied.

      Patients are followed every 6 months for 2 years and then annually for up to 13 years.

      PROJECTED ACCRUAL: A total of 1,360 patients (680 per treatment arm) will be accrued for this
      study within 9.5 years.
    

Intervention name(s): bicalutamide; goserelin; mitoxantrone hydrochloride; prednisone
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Casodex; Zoladex
Intervention MeSH terms: Prednisone; Goserelin; Mitoxantrone; Bicalutamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer