Patients with histologically proven prostate adenocarcinoma (non metastatic) MedDRA version: 9.1 Level: LLT Classification code 10029096 Term: Neoplasm prostate
Conditions
Interventions
Trade Name: TAXOTERE
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Docetaxel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Sponsors
G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Histologically proven prostate adenocarcinoma Er MRI to assess the disease extension and the prostate volume (endo-rectal), eventually Total PSA ≥ 20 ng/ml e ≤ 50 ng/ml and patients with PSA ≥ 50 ng/ml excluded. Other criteria described by nomograms findable on the website http//www.nomograms.org; Gleason score 8-10 by prostatic mapping T3a clinical staging Eventual presence of locoregional lynphonodal Cromogranin A Testosteron evaluation Bone scan if it suspects skeletal metastasis Coline TC-PET (to execute TC-PET to the beginning and the end of the treatment to estimate the pathologic staging; naturally to repeat the TC-PET to the end of treatment if to the beginning the TC-PET turned out positive) Age years:18 ≥ ≤ 75 Estimated life expectancy of at least 6 months Performance status ≤ 2 Adeguate bone marrow, renal and liver function: neutrophles count ≥ 1,500/mm3; platelets ≥ 100,000/mm3; haemoglobin ≥ 10 g/dL; bilirubin =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Distant metastases Active uncontrolled infections requiring intravenous antibiotic therapy Active peptic ulcer, uncontrolled diabetes mellitus or other controindications for cortisonic therapy Presence of any clinically significant cardiac arrhythmia, congestive heart failure (LVEF < 40%), myocardial infaction, unstable angina or coronary artery bypass graft in the previous six months Other severe or chronic medical or psychiatric condition that would impart, in the judgement of the investigator, excess risk associated with study participation or would make the patient inappropriate for entry into this study Other concomitant malignancies (other than treated carcinomas of the skin different from melanoma or other malignancies treated with curative intent) and no evidence of disease since, at least, five years Patients with extension extracapsulare disease at first diagnosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) Assessment of the pathologic response (percentage) after 4 cycles of neoadjuvant chemotherapy based on Docetaxel 75 mg/mq plus prednison 5 mg BID 2) Evaluation of the PSA response rate at every cycle 3) Determination of the Down- staging percentage 4) Evaluation of chemotherapy toxicity 5) Evaluation of proteins involved in cell cycle regulation and in apoptosis (p53, p21, Bcl2 e Bax) and of genes involved in prediction of tumour response to taxanes (Chfr, Snk/Plk2, Filamine A-B-C, YPEL) both on the biopsy at the diagnosis and after the neoadjuvant therapy with taxotere, in order to provide to the physician objective parameters to assess the probability of clinical response in each patient;Secondary Objective: 1) To evaluate the disease free survival (clinic or serologic) after two years of neoadjuvant chemotherapy based on Docetaxel following surgery and the hormone therapy in the locally advanced prostate adenocarcinoma (to determine the time of arising of hormone-refractoriness) 2) Determine the overall survival 3) Evaluate the time of treatment failure 4) Measure the ratio of PSA normalization 5) Quality of life analysis 6) Evaluate the variations of cromogranin A concentrations 7) Analysis of the role of ERK1/2 in the acquired resistance to taxotere, in relation to the expression of the above mentioned proteins and EGFR.;Primary end point(s): Assessment of the pathologic response (percentage) after 4 cycles of neoadjuvant chemotherapy based on Docetaxel 75 mg/mq plus prednison 5 mg BID | — |
Countries
Italy
Outcome results
None listed