Working… Menu
Trial record 56 of 1543 for:    Androgens

Safety Study of Sorafenib With Androgen Deprivation and Radiotherapy to Treat Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00924807
Recruitment Status : Terminated (Sponsor closed the trial)
First Posted : June 19, 2009
Results First Posted : March 17, 2015
Last Update Posted : December 11, 2018
Information provided by (Responsible Party):
Beth Israel Medical Center

Brief Summary:
The purpose of this study is to evaluate the safety of a new drug- sorafenib, which is to be administered at the same time as standard treatment, which includes hormonal therapy and external beam radiotherapy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Leuprolide acetate, Bicalutamide, Sorafenib Phase 1 Phase 2

Detailed Description:
Leuprolide acetate (a luteinizing hormone releasing hormone (LHRH) agonist) and Bicalutamide (an anti-androgen) are hormonal agents which are commonly used to reduce testosterone blood level for prostate cancer treatment. Intensity modulated external beam radiotherapy is a standard treatment for localized prostate cancer. Previous studies have shown that combining hormonal therapy and radiation is more effective than radiation alone. Unfortunately, significant percentages (50-75%) of patients still relapse. Sorafenib reduces the growth of cancer cells and has proven effective in the treatment of solid tumors including kidney and liver cancer. This drug is approved by the FDA for treatment kidney and liver cancer. The study investigators believe that adding sorafenib to standard treatment, comprising hormonal therapy and radiation, might be more effective then standard hormonal therapy.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Sorafenib Concurrent With Androgen Deprivation and Radiotherapy in the Treatment of Intermediate- and High-Risk Localized Prostate Cancer
Study Start Date : September 2008
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Androgen Depr, Radiotherapy, Sorafenib
Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.
Drug: Leuprolide acetate, Bicalutamide, Sorafenib
Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg
Other Names:
  • Leuprolide acetate
  • Bicalutamide
  • Sorafenib

Primary Outcome Measures :
  1. Determine the Safety and Maximally Tolerated Dose of Sorafenib Administered Concurrently With Radiotherapy in the Treatment of Intermediate- and High-risk Localized Prostate Cancer. [ Time Frame: Day 29 and every 2 weeks ]
    Data of zero ("0") participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study.

Secondary Outcome Measures :
  1. Biochemical Disease-free Survival [ Time Frame: after 9 months ]
    Data of zero ("0") participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have histologically confirmed intermediate or high risk prostate adenocarcinoma. Intermediate risk disease comprises T2b/c tumors, Gleason 7 histology, or PSA 10-20. High risk tumors comprise T3-4, Gleason 8 or higher histology, or PSA greater than 20.
  • Age > 18 years.
  • Life expectancy of greater than 5 years.
  • Patients must have normal organ and marrow function.
  • No pelvic lymph node metastases based on pelvic CT scan or MRI.
  • No bone metastasis. A whole body bone scan is required to rule out metastatic disease.

Exclusion Criteria:

  • Any previous, radiotherapy, or chemotherapy, or more than 4 weeks of androgen deprivation hormonal therapy for the treatment of prostate adenocarcinoma.
  • Patients may not be receiving any other investigational agents.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib or other agents used in this study.
  • Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
  • Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin will not be allowed to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00924807

Layout table for location information
United States, New York
St.Luke's-Roosevelt Hospital Center
New York, New York, United States, 10019
Sponsors and Collaborators
Beth Israel Medical Center
Layout table for investigator information
Principal Investigator: Seth Cohen, MD St. Luke's-Roosevelt Hospital Center

Layout table for additonal information
Responsible Party: Beth Israel Medical Center Identifier: NCT00924807     History of Changes
Other Study ID Numbers: IRB# 004-08
First Posted: June 19, 2009    Key Record Dates
Results First Posted: March 17, 2015
Last Update Posted: December 11, 2018
Last Verified: November 2018
Keywords provided by Beth Israel Medical Center:
Prostate Cancer
Combined Androgen Blockade
Additional relevant MeSH terms:
Layout table for MeSH terms
Androgen Antagonists
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Hormone Antagonists