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RAD001 and Bicalutamide for Androgen Independent Prostate Cancer

This study has been terminated.
(Low overall response rate)
Beth Israel Deaconess Medical Center
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute Identifier:
First received: February 28, 2008
Last updated: January 29, 2016
Last verified: January 2016
The goal of this clinical trial is to learn if the study drug RAD001 in combination with Bicalutamide can slow the growth of prostate cancer. The safety of RAD001 given together with Bicalutamide will also be studied. RAD001 has been shown to kill prostate cancer cells. In addition, several hundred kidney and heart transplant patients have been treated with the same main ingredient as in RAD001 for many years.

Condition Intervention Phase
Prostate Cancer
Drug: RAD001
Drug: Bicalutamide
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of RAD001 and Bicalutamide for Androgen Independent Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To Determine the Best Overall Response and Duration of Response, Taking Into Consideration Measurable Disease, Bone Metastases and PSA. [ Time Frame: 3 years ]
    The primary endpoint of this Phase II study is the best overall response, taking into consideration measurable disease, bone metastases, and PSA. A patient will be considered to have a favorable outcome if PSA declines in the absence of measurable disease without the appearance of new bone lesions, or if a response in measurable disease consistent with RECIST guidelines is observed, without an increase in PSA or the appearance of new bone lesions. Patients with stable disease lasting at least 6 months will also be considered to have favorable outcome.

Secondary Outcome Measures:
  • To Characterize the Toxicity Profile of RAD001 in Combination With Standard Dose Bicalutamide in Patients With Androgen Independent Prostate Cancer. [ Time Frame: 3 years ]

Enrollment: 36
Study Start Date: February 2008
Study Completion Date: January 2016
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD-001 in combination with bicalutamide
RAD001 will be administered orally as once daily dose of 10 mg (5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Bicalutamide will be administered orally as once daily dose of 50 mg (50 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.
Drug: RAD001
Taken orally once daily
Drug: Bicalutamide
Taken orally once daily

Detailed Description:
  • 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00630344

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Novartis Pharmaceuticals
Study Chair: Mary-Ellen Taplin, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Mary-Ellen Taplin, MD, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT00630344     History of Changes
Other Study ID Numbers: 07-316
Study First Received: February 28, 2008
Results First Received: January 20, 2014
Last Updated: January 29, 2016

Keywords provided by Dana-Farber Cancer Institute:
androgen independent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgen Antagonists
Hormone Antagonists
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents processed this record on May 23, 2017