Efavirenz in Treating Patients With Metastatic 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: NCT00964002
Recruitment Status : Unknown
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : August 24, 2009
Last Update Posted : September 7, 2009
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Efavirenz may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well efavirenz works in treating patients with metastatic prostate cancer.

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

Detailed Description:



  • To assess the effect of efavirenz on the non-PSA progression rate at 3 months in patients with castration-refractory metastatic prostate cancer.


  • To assess the effect of efavirenz on the PSA response at 3 months.
  • To assess the effect of efavirenz on overall survival.
  • To assess the effect of efavirenz on PSA progression-free survival.
  • To assess the effect of efavirenz on symptomatic progression-free survival.
  • To assess the tolerability and safety profile of efavirenz.

OUTLINE: This is a multicenter study.

Patients receive oral efavirenz once daily in the absence of disease progression or unacceptable toxicity.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial to Assess the Efficacy of Efavirenz in Metastatic Patients With Androgen-independent Prostate Cancer
Study Start Date : May 2008
Estimated Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Efavirenz

Primary Outcome Measures :
  1. Non-PSA progression rate at 3 months

Secondary Outcome Measures :
  1. PSA response rate at 3 months
  2. Overall survival
  3. PSA progression-free survival (PFS)
  4. Symptomatic PFS
  5. LINE 1 methylation level at baseline and 3 months
  6. Efavirenz blood concentration at 1 and 3 months
  7. Safety and tolerability as assessed by the incidence and type of adverse events according to NCI CTCAE, clinically significant laboratory abnormalities, and vital signs

Information from the National Library of Medicine

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


  • Histologically confirmed prostate cancer

    • Metastatic disease
    • Castration-refractory disease
  • No clinical symptoms related to disease progression


  • WHO performance status 0-2


  • Not specified

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): NCT00964002

Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Nadine Houede    33-556-333-333   
Sponsors and Collaborators
Institut Bergonié
Principal Investigator: Nadine Houede Institut Bergonié

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00964002     History of Changes
Other Study ID Numbers: CDR0000641767
IB 2008-23
First Posted: August 24, 2009    Key Record Dates
Last Update Posted: September 7, 2009
Last Verified: September 2009

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers