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Efavirenz in Treating Patients With Metastatic Prostate Cancer (FAVE)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
efavirenz
Sponsored by
Institut Bergonié
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring recurrent prostate cancer, stage IV prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Bergonie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Efavirenz

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 21, 2009
Last Updated
March 1, 2022
Sponsor
Institut Bergonié
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1. Study Identification

Unique Protocol Identification Number
NCT00964002
Brief Title
Efavirenz in Treating Patients With Metastatic Prostate Cancer
Acronym
FAVE
Official Title
A Phase II Trial to Assess the Efficacy of Efavirenz in Metastatic Patients With Androgen-independent Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 2008 (Actual)
Primary Completion Date
September 19, 2011 (Actual)
Study Completion Date
April 8, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Bergonié

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
recurrent prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Efavirenz
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
efavirenz
Primary Outcome Measure Information:
Title
Percentage of Participants Without Prostate-specific Antigen Progression at 3 Months
Description
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
Secondary Outcome Measure Information:
Title
Percentage of Participants Without Prostate-specific Antigen Progression at 6 Months
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadine Houede
Organizational Affiliation
Institut Bergonié
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25355844
Citation
Houede N, Pulido M, Mourey L, Joly F, Ferrero JM, Bellera C, Priou F, Lalet C, Laroche-Clary A, Raffin MC, Ichas F, Puech A, Piazza PV. A phase II trial evaluating the efficacy and safety of efavirenz in metastatic castration-resistant prostate cancer. Oncologist. 2014 Dec;19(12):1227-8. doi: 10.1634/theoncologist.2014-0345. Epub 2014 Oct 29.
Results Reference
result

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Efavirenz in Treating Patients With Metastatic Prostate Cancer

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