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
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the relative efficacy, in terms of overall survival, of the combination of
           androgen suppression and radiotherapy versus androgen suppression and radiotherapy
           followed by docetaxel and prednisone in patients with localized, high-risk prostate
           cancer.

      Secondary

        -  Compare the disease-free survival and incidence of adverse events in patients treated
           with these regimens.

        -  Compare the biochemical control, local control, and freedom from distant metastases in
           patients treated with these regimens.

        -  Determine the validity of prostate-specific antigen (PSA)-defined endpoints as a
           surrogate for overall survival of patients treated with these regimens.

        -  Compare the time interval between biochemical failure and distant metastases with
           respect to testosterone level in patients treated with these regimens.

      OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified
      according to risk group.

        -  Arm I: Patients receive androgen suppression therapy comprising luteinizing
           hormone-releasing hormone (LHRH) agonist (e.g., leuprolide acetate, goserelin,
           buserelin, or triptorelin) and oral antiandrogen (i.e., oral flutamide 3 times daily for
           2 months or oral bicalutamide once daily for 2 months). Beginning at week 8, patients
           undergo radiotherapy 5 days a week for approximately 8 weeks. Antiandrogen therapy is
           discontinued at completion of radiotherapy, but LHRH agonist therapy continues for 20
           months.

        -  Arm II: Patients receive androgen suppression therapy and undergo radiotherapy as in arm
           I. Beginning 4 weeks after completion of radiotherapy, patients receive docetaxel IV
           over 1 hour on day 1 and oral prednisone daily on days 1-21. Treatment repeats every 21
           days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
           Patients continue LHRH agonist therapy as in arm I.

      After completion of study treatment, patients are followed every 3 months for 2 years, every
      6 months for 3 years, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.
    

Intervention name(s): Dexamethasone; Prednisone; docetaxel; Oral antiandrogen; Radiation therapy; LHRH agonist
Intervention type(s): Drug; Drug; Drug; Drug; Radiation; Drug
Intervention description(s): 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.
Other intervention name(s): 3DCRT; Three-dimensional conformal radiotherapy; IMRT; Intensity-modulated radiation therapy
Intervention MeSH terms: Dexamethasone; Prednisone; Docetaxel; Androgen Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage IV prostate cancer