Bicalutamide With or Without Everolimus in Treating Patients With Recurrent or Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Bicalutamide; Everolimus
Intervention description: 50 mg oral tablet daily; 10 mg oral capsule daily
Intervention MeSH terms: Everolimus; Bicalutamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IV prostate cancer; adenocarcinoma of the prostate; recurrent prostate cancer

Summary:

      RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such
      as bicalutamide, may lessen the amount of androgens made by the body. Everolimus may stop the
      growth of tumor cells by blocking some of the enzymes needed for cell growth.

      PURPOSE: This phase II trial is studying bicalutamide and everolimus to see how well they
      work compared with bicalutamide in treating patients with recurrent or metastatic prostate
      cancer.
    

Eligibility criteria:

        Inclusion Criteria

          1. Participants must be adult males >18 years.

          2. Patients must have histologically or cytologically confirmed CaP with a Gleason score
             available or interpretable.

          3. Patients must have CaP deemed to be androgen independent.

          4. Measurable disease is not required.

          5. Patients must have been surgically or medically castrated. If the method of castration
             was LHRH agonists (leuprolide or goserelin) or antagonists (degarelix), then the
             patient must be willing to continue the use of LHRH agonists or antagonists. Serum
             testosterone must be at castrate levels (< 50 ng/dL) within 3 months prior to
             registration.

          6. Participant has not been on any previous therapy with androgen receptor antagonists or
             mTOR inhibitors. Note: patients who have taken an androgen receptor antagonist for a
             brief period (no more than 2 months) at the start of LHRH agonist therapy to prevent
             flare will be considered eligible.

          7. Men enrolled in this trial must agree to use adequate contraception prior to study
             entry and for the duration of study participation.

          8. Patients must have normal organ and marrow function.

          9. Ability to understand and the willingness to sign a written informed consent document

         10. ECOG performance status 0-2.

         11. Patients having any respiratory symptoms such as cough and shortness of breath have
             undergone pulmonary function testing revealing no worse than mild impairment.

        Exclusion Criteria

          1. No documented histological confirmation of CaP.

          2. Patient has received other hormonal therapy besides first-line androgen deprivation
             therapy with LHRH agonist, LHRH antagonist, orchiectomy, high-dose steroid,
             abiraterone, provenge and ketoconazole.

          3. Patients who have received prior treatment with an mTOR inhibitor.

          4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          5. HIV-positive patients receiving combination anti-retroviral therapy are excluded from
             the study because of possible pharmacokinetic interactions with RAD001.

          6. Patients currently receiving anticancer therapies or who have received anticancer
             therapies within 4 weeks of the start of study drug (including chemotherapy, radiation
             therapy, antibody based therapy, etc.)

          7. Patients who have had a major surgery or significant traumatic injury within 4 weeks
             of start of study drug, patients who have not recovered from the side effects of any
             major surgery (defined as requiring general anesthesia) or patients that may require
             major surgery during the course of the study.

          8. Prior treatment with any investigational drug within the preceding 4 weeks.

          9. Patients receiving chronic, systemic treatment with corticosteroids or another
             immunosuppressive agent.

         10. Patients should not receive immunization with attenuated live vaccines within one week
             of study entry or during study period.

         11. Patients on herbs or other alternative medicines for the treatment of prostate cancer,
             including but not limited to saw palmetto, PC-SPES.

         12. Uncontrolled brain or leptomeningeal metastases, including patients who continue to
             require glucocorticoids for brain or leptomeningeal metastases.

         13. Other malignancies within the past 3 years except for adequately treated basal or
             squamous cell carcinomas of the skin or other Stage 0 or I cancers.

         14. Impairment of gastrointestinal function or gastrointestinal disease that may
             significantly alter the absorption of RAD001.

         15. Patients with an active, bleeding diathesis.

         16. History of noncompliance to medical regimens.

         17. Patients unwilling to or unable to comply with the protocol.

         18. Patients with active pulmonary disorders or history of moderately to severely impaired
             pulmonary function tests will be excluded from the study.

         19. Patients with symptomatic metastatic prostate cancer such as moderate to severe pain,
             impaired organ function or spinal cord compression will be excluded from this study
             unless these issues have been taken care of.