Male patients aged 18 and over with castration-refractory metastatic prostate cancer histologically confirmed with WHO performance status ranged from 0 to 2, and without any clinical symptom related to disease progression. MedDRA version: 9.1 Level: LLT Classification code 10036947 Term: Prostatic cancer metastatic
Conditions
Interventions
Trade Name: SUSTIVA® 200 mg
Product Name: Efavirenz
Pharmaceutical Form: Capsule*
Sponsors
Institut Bergonié - Centre Régional de Lutte Contre le Cancer de Bordeaux et du Sud-ouest
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent prior any study-related procedures. 2. Male aged 18 years and over. 3. Previously confirmed histological diagnosis of prostate adenocarcinoma. 4. Evidence of metastases (including bone, lymph nodes, or other site), radiologically or histologically documented. 5. Despite a serum testosterone level inferior or equal to 50 ng/dL proving castration, evidence of biochemical progression of prostate cancer, documented by a rise in PSA that meets all the following criteria: a. 3 consecutive dosages of PSA, each of them showing an increase of the PSA value compared to the previous dosage (if the third PSA value is lower than the second PSA value, a fourth PSA assessment is required and the PSA value should be higher than the second PSA value) b. 2 weeks minimum time interval between sampling c. All PSA values must be equal or higher than 5 ng/mL and should have been assessed in the same laboratory using the same PSA assay 6. Word Health Organisation (WHO) performance status ranged from 0 to 2 (see Appendix 1). 7. No prior cytotoxic chemotherapy for the treatment of prostate cancer. 8. No clinical symptom related to disease progression: no bone pain related to bone metastasis, no change in the urinary symptoms during the last 6 months. 9. Treated with luteinising hormone-releasing hormone (LHRH) analogue and peripheral antiandrogens for 6 months at least and confirmation of the initial tumoral response at the start of this treatment. Continued elevation of the PSA can be demonstrated during the washout times provided above. 10. Withdrawal of antiandrogens, at least 6 weeks before inclusion in the study. LH-RH analogue should be maintained. 11. Biphosphonate therapy is allowed if the first dose was administered more than 30 days before inclusion. 12. Patients with French Social Security in compliance with the French law relating to biomedical research (Huriet Law 88-1138 and related decrees). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. No metastatic prostate cancer or no resistance to castration or symptomatic prostate cancer. 2. Radiotherapy or surgery or antiandrogens (except LHRH analogue) or bilateral orchiectomy within the 30 days preceding inclusion visit. Incompletely healed surgical incision. 3. Concomitant anticancer therapy other than surgical castration or continuous medical castration. 4. Previous treatment with chemotherapy including taxans or estracyt®. 5. Biology: a. Neutrophils 1.5 × the upper limit of reference range (ULRR) or creatinine clearance = 60 mL/ minute (calculated by the Cockcroft-Gault formula) c. Potassium 2.5 × ULRR; alkaline phosphatase (ALP) > 2.5 × ULRR, or > 5 × ULRR if judged by investigator to be related to liver metastasis; serum bilirubine > 1.5 × ULRR. 6. Human Immunodeficiency Virus (HIV) positive. 7. In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. currently unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) or evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study. 8. Previous or current malignancies other than prostate cancer within the last 5 years, with the exception of adequately treated basal cell or squamous cell carcinoma of the skin. 9. Known hypersensitivity to study treatment and to their excipients. 10. Severe hepatic impairment. 11. Concomitant treatment with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, rye alkaloids, voriconazole, herbal extract from St. John's wort (Hypericum perforatum). 12. Depressive status (with a score = 13 on the HAD scale). 13. Any unresolved toxicity greater than CTC grade 1 from previous anti-cancer therapy. 14. Currently active diarrhoea that may affect the ability of the patient to absorb the study treatment. 15. Previous exposure or any previous treatment acting on signal transduction pathway. 16. Participation in a clinical study and / or receipt of an investigational drug during the last 30 days. 17. Previous enrolment in the present study. 18. Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the effect of efavirenz on the non-PSA progression at 3 months in patients with castration-refractory metastatic prostate cancer, without any clinical symptom related to disease progression.;Secondary Objective: The secondary objective of the study is to investigate: - the effect of efavirenz on the PSA response at 3 months, - the effect of efavirenz on the overall survival, - the effect of efavirenz on the PSA progression-free survival, - the effect of efavirenz on the symptomatic progression-free survival, - the tolerability and safety profile of efavirenz. ;Primary end point(s): The non-PSA progression rate at 3 months and PSA response rate. | — |
Countries
France
Outcome results
None listed