Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer
Condition: PSA Level Greater Than Two; Stage IV Prostate Adenocarcinoma AJCC v7
MeSH terms: Adenocarcinoma
Intervention: Bicalutamide; Goserelin Acetate; Intensity-Modulated Radiation Therapy; Laboratory Biomarker Analysis; Leuprolide Acetate
Intervention description: Given PO; Given SC; Undergo IMRT; Correlative studies; Given via injection
Intervention MeSH terms: Leuprolide; Goserelin; Bicalutamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well hormone therapy and intensity-modulated radiation
      therapy work in treating patients with prostate cancer that has spread to other places in the
      body. Androgens can cause the growth of prostate cancer cells. Anti-hormone therapy using
      goserelin, leuprolide acetate, or bicalutamide, may lessen the amount of androgens made by
      the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.
      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. Giving hormone therapy and
      intensity-modulated radiation therapy may work better in treating patients with prostate
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with histologically proven diagnosis of adenocarcinoma of the prostate stage
             N1, N2, N3, M1a, M1b, M1c with =< 5 metastatic lesions; if the diagnosis of metastasis
             in the lymph node is based solely on imaging computed tomography (CT) scan or magnetic
             resonance imaging (MRI), the longitudinal diameter of the lymph node has to be >= 2.0
             cm; if the lymph node is positive on positron emission tomography (PET) or ProstaScint
             scan, the longitudinal diameter of the lymph node on CT scan or MRI has to be >= 1.5
             cm

          -  Patients who have measurable disease must have had X-rays, scans or physical
             examination used for tumor measurement completed within 28 days prior to registration;
             patients must have non-measurable disease assessed within 42 days prior to
             registration

          -  Patients must have had documented PSA of > 2 prior to onset of androgen deprivation

          -  Patients might have received up to 36 weeks of adjuvant androgen deprivation therapy
             and up to 36 weeks of androgen deprivation therapy for metastatic disease prior to
             enrollment to this study; patients may be on androgen deprivation for metastatic
             disease at the time of enrollment to the protocol; adjuvant therapy must have been
             completed at least 2 years before androgen deprivation for metastatic disease and
             patients must remain hormone sensitive

          -  Prior radiation therapy for metastatic disease is not allowed

          -  Prior chemotherapy for metastatic disease is not allowed; prior neoadjuvant and
             adjuvant chemotherapy is allowed; patients must have recovered from all acute
             side-effects related to previous systemic therapy

          -  Patients are allowed to receive one prior systemic non-chemotherapeutic treatment (i.
             e. immunotherapy, receptor tyrosine kinase inhibitor, antiangiogenic agent,
             differentiation agent) for recurrent or metastatic disease; patients must have
             recovered from all acute side-effects related to previous systemic therapy

          -  Use of bisphosphonates is allowed at the discretion of treating physician

          -  Patients must be capable of understanding the nature of the trial and must give
             written informed consent

          -  Patients must have a World Health Organization (WHO) performance status of 0, 1, or 2

        Exclusion Criteria:

          -  Patients with unstable or severe intercurrent medical conditions or active,
             uncontrolled infection

          -  Patients with a history of orchiectomy

          -  Patients undergoing therapy with other investigational agents; patients must have
             recovered from all acute effects of previously administered investigational agents and
             sufficient time must have elapsed since last administration to ensure the drug
             interactions not occur during this study

          -  Patients with a history of brain metastases or who currently have treated or untreated
             brain metastases

          -  Patients who have demonstrated refractoriness to hormone therapy with luteinizing
             hormone-releasing hormone (LHRH) agonist; refractoriness is defined as occurrence of
             one of the following while on therapy with LHRH agonist: increase in PSA by 25% over
             baseline (to at least > 2 ng/ml) on two consecutive PSA measurements, 20% increase in
             the sum of longest diameters of target measurable lesions over smallest sum observed
             (over baseline if no decrease during therapy) using the same techniques as baseline,
             clear worsening of any non-measurable disease, reappearance of any lesion that had
             disappeared, appearance of any new lesion