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Sorafenib in Treating Patients With Metastatic or Recurrent 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: NCT00093457
Recruitment Status : Completed
First Posted : October 8, 2004
Last Update Posted : April 9, 2020
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

Brief Summary:

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying the effectiveness of sorafenib in treating patients who have metastatic or recurrent prostate cancer that has not responded to previous hormone therapy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: sorafenib tosylate Phase 2

Detailed Description:


  • Determine the efficacy of sorafenib, as measured by prostate-specific antigen response, in patients with metastatic or recurrent hormone-refractory adenocarcinoma of the prostate.


  • Determine the objective response rate and duration of response in patients treated with this drug.
  • Determine the tolerability and toxicity of this drug in these patients.
  • Determine time to treatment failure and overall survival in patients treated with this drug.
  • Explore the relationship between measures of ras/raf pathway activation (pERK) and response to treatment in these patients.

OUTLINE: This is a non-randomized, multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks after going off study treatment and then periodically for survival. Patients with stable or responding disease, when they go off study treatment, are followed every 3 months until relapse or progression.

PROJECTED ACCRUAL: Approximately 15-25 patients will be accrued for this study within 12-18 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of BAY 43-9006 (NSC 724772; CTEP IND# 69,896) In Patients With Hormone Refractory Prostate Cancer
Actual Study Start Date : July 21, 2004
Actual Primary Completion Date : September 28, 2006
Actual Study Completion Date : January 18, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Intervention Details:
  • Drug: sorafenib tosylate
    BAY 43-9006 given orally at 400 mg BID in a 28 day cycle

Primary Outcome Measures :
  1. Prostate-specific antigen response and/or progression [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Objective response and/or progression [ Time Frame: 2 years ]
  2. Tolerability and toxicity [ Time Frame: 2 years ]
  3. Time to treatment failure and overall patient survival [ Time Frame: 2 years ]

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.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the prostate

    • Metastatic or recurrent disease
  • No curative standard therapy exists
  • Hormone-refractory disease

    • Evidence of prostate-specific antigen (PSA) progression during androgen ablation therapy, including medical or surgical castration

      • Documented PSA progression after completion of prior peripheral anti-androgens

        • At least a 25% increase (≥ 5 ng/mL) over a reference value PSA with 2 consecutive rising PSAs taken ≥ 1 week apart
      • Castrate level of testosterone ≤ 1.7 nmol/L for patients on medical androgen ablation

        • Patients receiving luteinizing hormone-releasing hormone agonist therapy must continue this treatment during study participation
  • PSA ≥ 10 ng/mL at the time of study entry
  • Primary tumor tissue (paraffin embedded) must be available for immunohistochemistry
  • Minimal symptomatic disease

    • No requirement for morphine or equivalent dose > 30 mg/day to control pain
  • No known brain metastases



  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 12 weeks


  • Absolute granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No evidence of bleeding diathesis


  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal


  • Serum creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min


  • No myocardial infarction within the past 6 months
  • No congestive heart failure
  • No unstable angina
  • No active cardiomyopathy
  • No unstable ventricular arrhythmia
  • No uncontrolled hypertension


  • No serious infection
  • No active peptic ulcer disease
  • No upper gastrointestinal or other condition that would preclude study compliance with oral medication
  • No uncontrolled psychotic disorder
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to sorafenib or other study agents
  • No other serious illness or medical condition that would preclude study participation
  • No other malignancy within the past 5 years except adequately treated non-melanoma skin cancer or other curatively treated solid tumor


Biologic therapy

  • Concurrent prophylactic filgrastim (G-CSF), sargramostim (GM-CSF), or other growth factors allowed for the management of adverse events only


  • No prior chemotherapy
  • No other prior cytotoxic chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • Concurrent steroids allowed provided there has been no increase in steroid requirements within the past 4 weeks AND no increase in dose is planned


  • At least 4 weeks since prior external-beam radiotherapy except low-dose non-myelosuppressive radiotherapy
  • Concurrent low-dose non-myelosuppressive palliative radiotherapy allowed


  • Not specified


  • No prior investigational anticancer agents
  • No concurrent therapeutic anticoagulation

    • Concurrent prophylactic low-dose warfarin for venous or arterial access devices allowed
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer therapy
  • No other concurrent investigational therapy
  • No concurrent grapefruit juice
  • Concurrent bisphosphonates allowed

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): NCT00093457

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Canada, Alberta
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
NCIC Clinical Trials Group
National Cancer Institute (NCI)
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Study Chair: Kim N. Chi, MD British Columbia Cancer Agency
Publications of Results:
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Responsible Party: NCIC Clinical Trials Group Identifier: NCT00093457    
Other Study ID Numbers: I167
CAN-NCIC-IND167 ( Other Identifier: PDQ )
CDR0000387987 ( Other Identifier: PDQ )
First Posted: October 8, 2004    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Canadian Cancer Trials Group ( NCIC Clinical Trials Group ):
recurrent prostate cancer
stage IV prostate cancer
adenocarcinoma of the prostate
Additional relevant MeSH terms:
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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