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

NCT ID: NCT00924807

Last Updated: 2018-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer

Keywords

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Prostate Cancer Combined Androgen Blockade Radiotherapy Sorafenib

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Androgen Depr, Radiotherapy, Sorafenib

Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.

Group Type EXPERIMENTAL

Leuprolide acetate, Bicalutamide, Sorafenib

Intervention Type DRUG

Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg

Interventions

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Leuprolide acetate, Bicalutamide, Sorafenib

Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg

Intervention Type DRUG

Other Intervention Names

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Leuprolide acetate Bicalutamide Sorafenib

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Beth Israel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seth Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's-Roosevelt Hospital Center

Locations

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St.Luke's-Roosevelt Hospital Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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SR06-959

Identifier Type: -

Identifier Source: secondary_id

IRB# 004-08

Identifier Type: -

Identifier Source: org_study_id