Efavirenz in Treating Patients With Metastatic Prostate Cancer

NCT00964002 | Completed Phase 2 Results DMC

• 5 other identifiers: CDR0000641767IB-FAVEIB 2008-23INCA-RECF0889EUDRACT-2008-002730-30
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

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

  6 months

Study Arms (1)

Efavirenz

EXPERIMENTAL

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).

Drug: efavirenz

Interventions

efavirenz DRUG

Efavirenz

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (1)

Institut Bergonie

Bordeaux, 33076, France

Location

Related Publications (1)

• 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.

  PMID: 25355844 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

efavirenz

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Pr Nadine Houede, oncologist
• Organization: Department of Medical Oncology, Institut bergonié

nadine.HOUEDE@chu-nimes.fr

Study Officials

• Nadine Houede

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2009
• First Posted: August 24, 2009
• Study Start: May 1, 2008
• Primary Completion: September 19, 2011
• Study Completion: April 8, 2014
• Last Updated: May 16, 2022
• Results First Posted: May 16, 2022

Record last verified: 2021-11

Locations

FR (1)