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
Intervention: bicalutamide; goserelin; mitoxantrone hydrochloride; prednisone
Intervention MeSH terms: Prednisone; Goserelin; Mitoxantrone; Bicalutamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 983.0
Sex: Male
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer

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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed stage T1-T3 adenocarcinoma of the prostate before radical
             prostatectomy and lymph node dissection

               -  Must have undergone prostatectomy within the past 120 days

          -  Must meet at least 1 of the following pathologic criteria:

               -  Gleason sum at least 8

               -  pT3b (seminal vesicle), pT4, or N1

               -  Gleason sum of 7 and positive margin

               -  Preoperative PSA greater than 15 ng/mL, Gleason score greater than 7, or PSA
                  level greater than 10 ng/mL and Gleason score greater than 6

          -  Must have an undetectable PSA (no greater than 0.2 ng/mL) documented after surgery or
             prior to adjuvant hormonal therapy (for patients initiating adjuvant hormonal therapy
             prior to study)

          -  No evidence of metastatic disease on bone scan if PSA is 20 ng/mL or greater at
             clinical diagnosis

          -  No distant metastatic disease

        PATIENT CHARACTERISTICS:

        Performance status:

          -  SWOG 0-1

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Not specified

        Hepatic:

          -  Not specified

        Renal:

          -  Not specified

        Cardiovascular:

          -  No uncontrolled congestive heart failure

          -  If history of cardiac disease, LVEF at least 50% by MUGA scan or 2-D echocardiogram

        Other:

          -  No HIV positivity

          -  No other prior malignancy within the past 5 years except adequately treated basal cell
             or squamous cell skin cancer or stage I or II cancer that is currently in complete
             remission

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  Not specified

        Endocrine therapy:

          -  Prior neoadjuvant hormonal therapy of no more than 4 months duration before radical
             prostatectomy allowed

          -  Other concurrent adjuvant hormonal therapy allowed if initiated prior to study

          -  Concurrent low-dose megestrol (less than 40 mg/day) for hot flashes allowed

        Radiotherapy:

          -  No prior radiotherapy

          -  No concurrent whole pelvis irradiation

          -  Concurrent radiotherapy allowed at the discretion of the physician

        Surgery:

          -  See Disease Characteristics

          -  See Endocrine therapy

          -  Recovered from prior surgery

        Other:

          -  No other prior or concurrent therapy for adenocarcinoma of the prostate