Efavirenz in Treating Patients With Metastatic Prostate Cancer

Phase 2

Completed

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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Efavirenz	efavirenz	Patients will receive efavirenz 600 mg daily as oral tablets at bedtime and in fast condition (1-2 hours far from dinner) until objective biological, radiological or clinical disease progression or study discontinuation (withdrawal of consent or when the patient meets one criterion for treatment discontinuation). Individual dose escalation will be possible: if biological progression occurs at month 3, dose could be increased to 1200 mg/day in asymptomatic and non radiological progression patients (by step of 200 mg every 15 days).

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Without Prostate-specific Antigen Progression at 3 Months	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 Outcome Measures

Name	Time	Method
Percentage of Participants Without Prostate-specific Antigen Progression at 6 Months	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.