Prostate Cancer
Conditions
Keywords
recurrent prostate cancer, stage IV prostate cancer
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.
Interventions
DRUGefavirenz
Sponsors
Institut Bergonié
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
efavirenz | 61 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 8 |
Baseline characteristics
| Characteristic | Efavirenz |
|---|---|
| Age, Continuous | 71 years |
| Region of Enrollment France | 61 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 11 / 59 |
Outcome results
Primary
Percentage of Participants Without Prostate-specific Antigen Progression at 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.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Efavirenz | Percentage of Participants Without Prostate-specific Antigen Progression at 3 Months | 28.3 percentage of participants |
Secondary
Percentage of Participants Without Prostate-specific Antigen Progression at 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.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Efavirenz | Percentage of Participants Without Prostate-specific Antigen Progression at 6 Months | 11.3 percentage of participants |