Patients with advanced or metastatic hormone-refractory prostate cancer MedDRA version: 9.1 Level: LLT Classification code 10029096 Term: Neoplasm prostate
Conditions
Interventions
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Ketoconazole
Concentration unit: % percent
Concentration type: equal
Concentration number: 40-
Sponsors
ISTITUTO NAZIONALE PER LA CURA TUMORI
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 18 years of age or older. Written informed consent provided. Histological or cytological confirmation of adenocarcinoma of the prostate. At least one previous hormonal treatment including LH-RH analogue and antiandrogen. Patients previously treated with an hormonal treatment must have evaluable disease progression defined by RECIST criteria. Karnofsky performance status ≥ 60%. Adequate hematologic (WBC ≥ 3,000/μl, ANC≥1,500/μl, platelet count ≥ 100,000/μl), hepatic (bilirubin level within normal limits, AST and ALT ≤ 1.5 x the upper normal limit) and renal functions (serum creatinine level ≤ 1.5 the upper limit of normal). Patients with reproductive potential must use effective contraception. Concurrent biphosphonates can be allowed provided treatment was initiated at least 4 weeks prior to study entry. Life expectancy of at least 6 months. 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: None previous medical antitumor therapy, while are allowed one or more chemotherapy regimen. Patients who have gone under surgery for any cause less than 4 weeks prior to study entry. Clinical evidence of brain metastases or history of brain metastases. Previous or current malignancies at other sites with the exception of adequately treated non melanoma skin cancer, and any other malignancies with an interval free from progression within 5 years. Current enrolment in another therapeutic clinical trial. Any other disease of SNC or PNS. A history of non compliance to medical regimen or inability or unwillingness to return for all scheduled visits. Is allowed radiotherapy on bone lesions whose are not the only parameter of disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the biochemical responses as determined by PSA value.;Secondary Objective: Determine the treatment activity in terms of objective responses. Determine the toxicity profile of Chetoconazolo.;Primary end point(s): To evaluate the biochemical responses as determined by PSA value. | — |
Countries
Italy
Outcome results
None listed