RAD001 and Bicalutamide for Androgen Independent Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: RAD001; Bicalutamide
Intervention MeSH terms: Everolimus; Bicalutamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RAD001; bicalutamide; androgen independent prostate cancer

Summary:

      In the treatment of castration-resistant prostate cancer (CRPC), therapies will long response
      durations remain elusive as a result of the inherent ability of prostate cancer cells to
      develop iterative resistance. The goal of this study is to learn if the study drug RAD001
      together with Bicalutamide can slow the growth of prostate cancer. The safety of the
      combination will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Histologically documented prostate cancer

          -  Castration resistant prostate cancer defined as two rising PSAs on castration therapy

          -  Baseline PSA of 2ns/mL or greater

          -  Testosterone of 50ng/mL or less

          -  Patients on LHRH agonist/antagonist must continue therapy at the recommended dosing
             intervals

          -  Prior bicalutamide is allowed as long as treatment was for 6 months or longer

          -  Metastatic disease is not required

          -  Minimum of four weeks since any major surgery, completion of radiation, or completion
             of all prior systemic anticancer therapy

          -  ECOG Performance Status equal to or less than 2

          -  Adequate bone marrow and liver function as outlined by parameters in the protocol

        Exclusion Criteria:

          -  Prior treatment with any investigational drug within the preceding 4 weeks

          -  Prior treatment with an mTOR inhibitor

          -  Fasting lipids over the parameters outlined in the protocol

          -  Chronic treatment with systemic steroids or another immunosuppressive agent

          -  Patients should not receive immunization with attenuated live vaccines during study
             period or within one week of study entry

          -  Uncontrolled brain or leptomeningeal metastases, including patients who continue to
             require glucocorticoids for brain or leptomeningeal metastases

          -  Other malignancies within the past 3 years except for adequately treated or basal
             squamous cell carcinomas of the skin

          -  Patients who have any severe and/or uncontrolled medical conditions or other
             conditions that could affect their participation in the study

          -  Known history of HIV seropositivity

          -  Impairment of gastrointestinal function or gastrointestinal disease that may
             significantly alter the absorption of RAD001

          -  Patients with an active, bleeding diathesis or on oral anti-vitamin K medication
             (except low dose coumarin)

          -  Men able to conceive and unwilling to practice an effective method of birth control

          -  Known hypersensitivity to RAD001 or other rapamycins or to its excipients

          -  History of noncompliance to medical regimens