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

Study Overview
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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.

Official Title
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Phase I/II Study of Sorafenib Concurrent With Androgen Deprivation and Radiotherapy in the Treatment of Intermediate- and High-Risk Localized Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Leuprolide acetate, Bicalutamide, Sorafenib


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Androgen Depr, Radiotherapy, Sorafenib<br>Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy. | Drug: Leuprolide acetate, Bicalutamide, Sorafenib<br>* Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg<br>* Other names: Sorafenib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the Safety and Maximally Tolerated Dose of Sorafenib Administered Concurrently With Radiotherapy in the Treatment of Intermediate- and High-risk Localized Prostate Cancer. | 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. | Day 29 and every 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical Disease-free Survival | 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. | after 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Combined Androgen Blockade, Radiotherapy, Sorafenib