SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: bicalutamide; goserelin acetate; clinical observation
Intervention description: Given orally; Given subcutaneously; Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease.
Intervention MeSH terms: Goserelin; Bicalutamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3040.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; stage IV prostate cancer; recurrent prostate cancer

Summary:

      RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy
      may be effective treatment for prostate cancer. It is not yet known which regimen of hormone
      therapy is most effective for stage IV prostate cancer.

      PURPOSE: This randomized phase III trial is studying two different regimens of hormone
      therapy and comparing how well they work in treating men with stage IV prostate cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed adenocarcinoma of the prostate

               -  Metastatic stage IV (stage D2)

                    -  Any number of bone metastases by bone scan allowed

                    -  Unequivocal visceral organ metastases (liver, brain, or lung) allowed

               -  No suspected second primary tumors unless metastases are histologically
                  confirmed, including special stains (e.g., prostate specific antigen [PSA] and
                  prostatic alkaline phosphatase [PAP])

          -  For entry into late induction therapy:

               -  No more than 1 month from the beginning of antiandrogen therapy to the beginning
                  of luteinizing hormone-releasing hormone (LHRH) agonist therapy

               -  No more than 6 months since initiation of current combined androgen-deprivation
                  therapy (LHRH agonist and antiandrogen)

               -  The effectiveness of the current depot LHRH agonist would not extend beyond 8
                  months after initiation of combined androgen therapy

          -  PSA at least 5 ng/mL

          -  No acute spinal cord compression

        PATIENT CHARACTERISTICS:

        Age:

          -  Adult

        Performance status:

          -  SWOG 0-2

        Hematopoietic:

          -  Not specified

        Hepatic:

          -  Not specified

        Renal:

          -  Not specified

        Other:

          -  Recovered from any major infection

          -  No active medical illness that would preclude study or limit survival

          -  No other malignancy within the past 5 years except:

               -  Adequately treated basal cell or squamous cell skin cancer

               -  Adequately treated carcinoma in situ of the bladder

               -  Adequately treated other superficial cancer

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No concurrent biological response modifier therapy

        Chemotherapy:

          -  No concurrent chemotherapy

        Endocrine therapy:

          -  See Disease Characteristics

          -  More than 1 year since any prior neoadjuvant or adjuvant hormonal therapy for a
             duration of no more than 4 months

               -  Single or combination therapy allowed

          -  More than 1 year since prior finasteride for prostate cancer for a duration of no more
             than 9 months (less than 6 months for benign prostatic hypertrophy)

          -  Prior or concurrent megestrol for hot flashes allowed

          -  No other concurrent hormonal therapy

        Radiotherapy:

          -  No concurrent radiotherapy other than palliation of painful bone metastases

        Surgery:

          -  No prior bilateral orchiectomy

          -  Recovered from any prior major surgery