Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Dexamethasone; Prednisone; docetaxel; Oral antiandrogen; Radiation therapy; LHRH agonist
Intervention description: Premedication of dexamethasone prior to docetaxel, per institutional standards.; 10 mg orally per day until day 21 of the last cycle of docetaxel, beginning 28 days after the completion of RT.; 75 mg/m2 i.v. over 1 hour (on day 1 of each cycle) every 21 days for 6 cycles, beginning 28 days after the completion of RT.; Oral antiandrogen of treating institution's choice to be given per package instructions for 8 weeks, then concurrent with radiation therapy. Treatment is discontinued at the end of radiation therapy.; 46.8 Gy, using either three-dimensional conformal radiotherapy (3DCRT) or intensity-modulated radiation therapy (IMRT), will be given to the regional lymphatics followed by a 25.2-28.8 Gy boost to the prostate, to bring the total dose to the prostate to 72.0-75.6 Gy. Daily prescription doses will be 1.8 Gy per day, 5 days per week x 8-8.5 weeks, beginning 8 weeks after the initiation of androgen suppression.; LHRH agonist of treating institution's choice to be given per package instructions for 8 weeks, then concurrent with radiation therapy, and then until 24 months from initiation of any treatment has been reached.
Intervention MeSH terms: Dexamethasone; Prednisone; Docetaxel; Androgen Antagonists
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 612.0
Sex: Male
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage III prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage IV prostate cancer

Summary:

      RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy using
      drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may fight prostate cancer
      by lowering the amount of androgens the body makes. Radiation therapy uses high-energy x-rays
      to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and prednisone, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. It is not yet known whether giving hormone therapy and radiation therapy
      together with chemotherapy is more effective than giving hormone therapy together with
      radiation therapy in treating prostate cancer.

      PURPOSE: This randomized phase III trial is studying hormone therapy and radiation therapy
      followed by docetaxel and prednisone to see how well it works compared to hormone therapy and
      radiation therapy in treating patients with localized prostate cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed prostate cancer at high-risk for recurrence within the past
             180 days as determined by 1 of the following combinations (risk groups):

               -  Gleason score ≥ 9, prostate-specific antigen (PSA) ≤ 150 ng/mL, and any T stage

               -  Gleason score 8, PSA < 20 ng/mL, and stage ≥ T2

               -  Gleason score 8, PSA 20-150 ng/mL, and any T stage

               -  Gleason score 7, PSA 20-150 ng/mL, and any T stage

          -  Clinically negative lymph nodes by imaging (pelvic CT scan or pelvic MRI), nodal
             sampling, or dissection within 90 days prior to study entry

               -  Equivocal or questionable lymph nodes ≤ 1.5 cm by imaging allowed

               -  Positive lymph nodes by capromab pendetide (ProstaScint^®) scan with a
                  corresponding lymph node ≤ 1.5 cm by CT scan or MRI allowed

          -  PSA ≤ 150 ng/mL

               -  Cannot have been obtained during any of the following time points:

                    -  10-day period after prostate biopsy

                    -  After initiation of hormonal therapy

                    -  Within 30 days after discontinuation of finasteride

                    -  Within 90 days after discontinuation of dutasteride

          -  No distant metastases by physical exam and bone scan

               -  Equivocal bone scan findings allowed if plain films are negative

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-1

          -  Platelet count ≥ 100,000/mm^3

          -  Absolute neutrophil count ≥ 1,800/mm^3

          -  Hemoglobin ≥ 8 g/dL (transfusion or other intervention allowed)

          -  Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times upper
             limit of normal (ULN)

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  Bilirubin ≤ 1.5 times ULN

          -  Fertile patients must use effective contraception during and for at least 3 months
             after completion of study treatment

          -  No prior invasive malignancy, except nonmelanomatous skin cancer or other malignancy,
             unless disease-free for ≥ 3 years (e.g., carcinoma in situ of the oral cavity or
             bladder are allowed)

          -  No unstable angina and/or congestive heart failure requiring hospitalization within
             the past 6 months

          -  No transmural myocardial infarction within the past 6 months

          -  No acute bacterial or fungal infection requiring intravenous antibiotics

          -  No AIDS

          -  No prior allergic reaction to any study drugs or other drugs formulated with
             polysorbate 80

          -  No existing peripheral neuropathy ≥ grade 2

        PRIOR CONCURRENT THERAPY:

          -  At least 60 days since prior 5-alpha reductase inhibitor (e.g., finasteride) for
             prostatic hypertrophy

          -  At least 90 days since prior testosterone

          -  Prior pharmacologic androgen ablation for prostate cancer allowed provided androgen
             ablation was initiated no more than 50 days prior to study entry

          -  No prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral
             orchiectomy

          -  No prior systemic chemotherapy for prostate cancer

               -  Prior chemotherapy for a different cancer is allowed

          -  No prior radiotherapy, including brachytherapy, to the region of prostate cancer that
             would result in overlap of radiotherapy fields

          -  Intensity modulated radiotherapy allowed