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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

Phase 1/Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

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

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

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

determine the safety and maximally tolerated dose of sorafenib administered concurrently with radiotherapy in the treatment of intermediate- and high-risk localized prostate cancer.

Outcome Time Frame:

Day 29 and every 2 weeks

Safety Issue:


Principal Investigator

Seth Cohen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Luke's-Roosevelt Hospital Center


United States: Institutional Review Board

Study ID:

IRB# 004-08



Start Date:

September 2008

Completion Date:

December 2013

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Combined Androgen Blockade
  • Radiotherapy
  • Sorafenib
  • Prostatic Neoplasms



St.Luke's-Roosevelt Hospital CenterNew York, New York  10019