Skip to main content
OpenTrials
Completed

NCT Number: NCT00964002

Efavirenz in Treating Patients With Metastatic Prostate Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–120 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Institut Bergonie

Bordeaux, 33076, France

About this study

OBJECTIVES:

Primary

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

Secondary

  • To assess the effect of efavirenz on the PSA non-progression rate at 6 months.
  • To assess the effect of efavirenz on overall survival.
  • To assess the effect of efavirenz on PSA 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer
  • Metastatic disease
  • Castration-refractory disease
  • No clinical symptoms related to disease progression

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2

PRIOR CONCURRENT THERAPY:

  • Not specified

Treatment and study plan

Efavirenz

Drug

Primary outcomes

  1. Percentage of Participants Without Prostate-specific Antigen Progression at 3 Months

    Time frame: 3 months

    Prostate-specific antigen (PSA) non-progression rate is defined as the rate of patients with the absence of PSA progression.

    PSA progression is defined as follows :

    • In patients whose PSA has not decreased, progressive disease is a 25% increase over the baseline (on-study) and an increase in the absolute-value PSA level by at least 5 ng/mL, which is confirmed by a second value.
    • In patients whose PSA has decreased but has not reached response criteria, progressive disease would be considered to have occurred when PSA increases 25% over the nadir, provided that the increase is a minimum of 5 ng/mL and is confirmed.

    For the 3-month evaluation, patients who died within the 3 first months will be considered as progressions.

    PSA assessment is to be performed every 28 days in the first 6 months after inclusion then every 3 months until progression or end of treatment. PSA assessment to establish eligibility is to be obtained from the same local laboratory using the same PSA assay.

Secondary outcomes

  1. Percentage of Participants Without Prostate-specific Antigen Progression at 6 Months

    Time frame: 6 months

    Prostate-specific antigen (PSA) non-progression rate is defined as the rate of patients with the absence of PSA progression.

    PSA progression is defined as follows :

    • In patients whose PSA has not decreased, progressive disease is a 25% increase over the baseline (on-study) and an increase in the absolute-value PSA level by at least 5 ng/mL, which is confirmed by a second value.
    • In patients whose PSA has decreased but has not reached response criteria, progressive disease would be considered to have occurred when PSA increases 25% over the nadir, provided that the increase is a minimum of 5 ng/mL and is confirmed.

    For the 6-month evaluation, patients who died within the 6 first months will be considered as progressions.

    PSA assessment is to be performed every 28 days in the first 6 months after inclusion then every 3 months until progression or end of treatment. PSA assessment to establish eligibility is to be obtained from the same local laboratory using the same PSA assay.

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Registry information

Official study title

A Phase II Trial to Assess the Efficacy of Efavirenz in Metastatic Patients With Androgen-independent Prostate Cancer

Acronym: FAVE

Important dates

Study start
2008
Primary completion
2011
Study completion
2014
First posted
Aug 24, 2009
Registry last updated
May 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.