Phase II Trial of Bicalutamide + RAD001 in Patients With Hormone-Independent Prostatic Adenocarcinoma (HIPC) After the First-Line Androgen Deprivation Therapy

Inclusion 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.