Prostate Cancer MedDRA version: 9.1 Level: LLT Classification code 10060862 Term: Prostate cancer
Conditions
Sponsors
Meletios Athanasios Dimopoulos
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Histologically proven prostate cancer 2. PSA and/or clinical (including radiological) progression despite androgen deprivation (castration testosterone levels) (PSA progression:>=25% increase from baseline confirmed at least one week later) 3. Adequate antiadrogen withdrawal time (4 weeks for flutamide or nilutamide and 6 weeks for bicalutamide) 4. No prior chemotherapy 5. PSA at progression >=20 ng/ml 6. ECOG PS 0-2 7. Adequate bone marrow, renal and liver function (platelets = 100.000/ul, white blood cells = 3.000/ul or neutrophil count = 1.500/ul,, creatinine = 1.5 mg/dl, hepatic transaminases = 2.5 x ULN, serum total bilirubin = 1.5 x ULN) 8. Available archive material for PTEN screening or presence of lesions which could be biopsied (prostate, lymph nodes, liver, lung, soft tissue) 9. Signed written informed consent 10. Life expectancy >=3months 11. Age = 18 years old 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. Less than 4 weeks from prior radiotherapy or radionuclide therapy 2. ECOG PS>2 3. Significant co-morbid disease, which prohibits the conduction of chemotherapy, such as active systemic infection, symptomatic cardiac or pulmonary disease, or psychiatric disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Correlation of PTEN expression in biopsies from primary tumor and metastases with PSA response;Secondary Objective: Secondary objectives: 1. Overall survival (OS) 2.Time to progression (TTP) 3. Objective response rate (RR) (RECIST) 4. Quality of life 5. Correlation of response with EGFR and pAkt expression 6. Toxicity 7. Correlation of PSA decline of at least 30% with PTEN loss 8. Correlation of clinical responses not qualifying for PR with PTEN loss;Primary end point(s): The primary target variable will be PSA response in correlation with PTEN expression | — |
Countries
Greece
Outcome results
None listed