Docetaxel, Androgen Ablation, and External-Beam Radiation Therapy in Patients With High-Risk Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: 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
      leuprolide, may lessen the amount of androgens made by the body. Radiation therapy uses high
      energy x-rays to kill tumor cells. Giving docetaxel together with androgen ablation therapy
      and external-beam radiation therapy may kill more tumor cells.

      PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when
      given together with androgen ablation therapy and external-beam radiation therapy and to see
      how well they work in treating patients with high-risk localized prostate cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the dose-limiting toxicity and maximum tolerated dose of docetaxel when
           administered in combination with androgen ablation therapy and adaptive external-beam
           radiotherapy in patients with high-risk localized adenocarcinoma of the prostate.

      Secondary

        -  Determine the 2-year biochemical progression-free survival of patients treated with this
           regimen.

      OUTLINE: This is a multicenter, open-label, dose-escalation study of docetaxel.

        -  Androgen ablation therapy: Patients receive leuprolide acetate or other luteinizing
           hormone-releasing hormone agonist beginning 2-3 months prior to the start of
           chemoradiotherapy and continuing for up to 2 years.

        -  Chemoradiotherapy: Patients receive docetaxel IV over 1 hour on day 1 and high-dose
           external-beam radiotherapy on days 1-5. Treatment repeats every 7 days for 8 courses in
           the absence of disease progression or unacceptable toxicity.

      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.

      After completion of study treatment, patients are followed every 3 months.
    

Intervention name(s): docetaxel; leuprolide acetate; radiation therapy
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.; Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.; The total dose will be 7800 cGy in 200 centigray (cGy) per fraction for a total of 39 treatments.
Other intervention name(s): Taxotere; Lupron; Eligard; Viadur; Zoladex
Intervention MeSH terms: Docetaxel; Leuprolide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer