Radiation Therapy, Docetaxel, and Hormone Therapy in High-Risk Locally Advanced Metastasized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Specialized radiation therapy that delivers a high- dose of radiation directly to
      the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in
      chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells,
      either by killing the cells or by stopping them from dividing. Androgens can cause the growth
      of prostate cancer cells. Antihormone therapy, such as goserelin and bicalutamide, may lessen
      the amount of androgens made by the body. Giving radiation therapy together with chemotherapy
      and hormone therapy may kill more tumor cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when
      given together with intensity-modulated radiation therapy and hormone therapy in treating
      patients with high-risk locally advanced prostate cancer with pelvic lymph node metastasis.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine, preliminarily, the grade III or IV toxicity rate of concurrent extended-field
           intensity-modulated radiotherapy (IMRT), docetaxel, and androgen deprivation therapy in
           patients with high-risk, locally advanced prostate cancer with pelvic lymph node
           metastasis.

      Secondary

        -  Determine, preliminarily, the progression-free survival of patients treated with this
           regimen.

        -  Determine the maximum tolerated dose of docetaxel when administered with concurrent IMRT
           in this patients.

      OUTLINE: This is a dose-escalation study of docetaxel.

      Patients receive combined androgen deprivation therapy (if not already on combined hormonal
      therapy) comprising goserelin acetate* subcutaneously once every 3 months for up to 2 years
      and oral bicalutamide once daily beginning on day 1 and continuing until the completion of
      radiotherapy. Beginning at approximately week 9 of androgen deprivation therapy, patients
      receive docetaxel IV over 1 hour once weekly for up to 9 weeks. Concurrently with
      chemotherapy, patients undergo intensity-modulated radiotherapy 5 days a week for up to 45
      fractions (9 weeks).

      Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
      of 6 patients experience dose-limiting toxicity.

      Note: *Not required for patients who have undergone bilateral orchiectomy

      After completion of study therapy, patients are followed periodically for 5 years.
    

Intervention name(s): bicalutamide; docetaxel; goserelin; intensity-modulated radiation therapy
Intervention type(s): Drug; Drug; Drug; Radiation
Other intervention name(s): Casodex; Docefrez, Taxotere; Zoladex
Intervention MeSH terms: Docetaxel; Goserelin; Bicalutamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I prostate cancer; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer; adenocarcinoma of the prostate; recurrent prostate cancer