Trial Outcomes & Findings for Efavirenz in Treating Patients With Metastatic Prostate Cancer (NCT NCT00964002)

Last Updated: 2022-05-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

3 months

Results posted on

2022-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	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). As dose increase is protocol/standard and we are not in a dose escalation trial (Phase I), patients with dose escalation will not be described or analyzed for the primary endpoint.
Overall Study STARTED	61
Overall Study Assessable for Safety	59
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	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). As dose increase is protocol/standard and we are not in a dose escalation trial (Phase I), patients with dose escalation will not be described or analyzed for the primary endpoint.
Overall Study Protocol Violation	8

Baseline Characteristics

Efavirenz in Treating Patients With Metastatic Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Efavirenz n=61 Participants 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
Age, Continuous	71 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants
Region of Enrollment France	61 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Efavirenz n=53 Participants 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
Percentage of Participants Without Prostate-specific Antigen Progression at 3 Months	28.3 percentage of participants Interval 16.8 to 42.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Efavirenz n=53 Participants 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
Percentage of Participants Without Prostate-specific Antigen Progression at 6 Months	11.3 percentage of participants Interval 4.3 to 23.0

Adverse Events

Efavirenz

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Efavirenz n=59 participants at risk 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
Psychiatric disorders Psychosis	3.4% 2/59 • Number of events 2 Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
Psychiatric disorders Confusion	1.7% 1/59 • Number of events 1 Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
Gastrointestinal disorders Abdominal pain	1.7% 1/59 • Number of events 1 Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
Musculoskeletal and connective tissue disorders Back pain	1.7% 1/59 • Number of events 1 Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
Infections and infestations Sepsis	1.7% 1/59 • Number of events 1 Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
Renal and urinary disorders Urinary tract obstruction	1.7% 1/59 • Number of events 1 Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
Renal and urinary disorders Urinary retention	1.7% 1/59 • Number of events 1 Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
Vascular disorders Thromboembolic event	1.7% 1/59 • Number of events 1 Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
Injury, poisoning and procedural complications Aortic injury	1.7% 1/59 • Number of events 1 Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
Cardiac disorders Atrial fibrillation	1.7% 1/59 • Number of events 1 Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.

Other adverse events

Adverse event data not reported

Additional Information

Pr Nadine Houede, oncologist

Department of Medical Oncology, Institut bergonié

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place