Back to resultsSafety Study of Sorafenib With Androgen Deprivation and Radiotherapy to Treat Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Leuprolide acetate, Bicalutamide, Sorafenib
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Combined Androgen Blockade, Radiotherapy, Sorafenib
Eligibility Criteria
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.
Sites / Locations
- St.Luke's-Roosevelt Hospital Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Androgen Depr, Radiotherapy, Sorafenib
Arm Description
Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00924807
First Posted
June 17, 2009
Last Updated
November 26, 2018
Sponsor
Beth Israel Medical Center
Collaborators
Bayer
1. Study Identification
Unique Protocol Identification Number
NCT00924807
Brief Title
Safety Study of Sorafenib With Androgen Deprivation and Radiotherapy to Treat Prostate Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Sponsor closed the trial
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Medical Center
Collaborators
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Combined Androgen Blockade, Radiotherapy, Sorafenib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Androgen Depr, Radiotherapy, Sorafenib
Arm Type
Experimental
Arm Description
Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.
Intervention Type
Drug
Intervention Name(s)
Leuprolide acetate, Bicalutamide, Sorafenib
Other Intervention Name(s)
Leuprolide acetate, Bicalutamide, Sorafenib
Intervention Description
Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg
Primary Outcome Measure Information:
Title
Determine the Safety and Maximally Tolerated Dose of Sorafenib Administered Concurrently With Radiotherapy in the Treatment of Intermediate- and High-risk Localized Prostate Cancer.
Description
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.
Time Frame
Day 29 and every 2 weeks
Secondary Outcome Measure Information:
Title
Biochemical Disease-free Survival
Description
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.
Time Frame
after 9 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seth Cohen, MD
Organizational Affiliation
St. Luke's-Roosevelt Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
St.Luke's-Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety Study of Sorafenib With Androgen Deprivation and Radiotherapy to Treat Prostate Cancer
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