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A Phase II Trial of RAD001 and Bicalutamide for Androgen Independent Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

A Phase II Trial of RAD001 and Bicalutamide for Androgen Independent Prostate Cancer

- Participants will be given a study medication-dosing calendar for each treatment cycle.
Each treatment cycle lasts four weeks during which time participants will take RAD001
and bicalutamide orally, once per day. RAD001 will be provided from the research
pharmacy at the hospital and a prescription will be given for bicalutamide to obtain
from a local pharmacy.

- A history, physical exam, and blood tests will be performed every four weeks. An
assessment of the tumor by Chest CT scan, chest x-ray, bone scan, and abdomen/pelvis CT
or MRI will be performed every 12 weeks.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the best overall response and duration of response, taking into consideration measurable disease, bone metastases and PSA.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Mary-Ellen Taplin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

December 2013

Related Keywords:

  • Prostate Cancer
  • RAD001
  • bicalutamide
  • androgen independent prostate cancer
  • Prostatic Neoplasms



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115