eoadjuvant chemotherapy in patients affected by prostatic cancer locally advanced (non metastatic. Phase II study - ND

• Conditions: Patients with histologically proven prostate adenocarcinoma (non metastatic); MedDRA version: 9.1Level: LLTClassification code 10029096Term: Neoplasm prostate

• Registration Number: EUCTR2007-002909-49-IT
• Lead Sponsor: G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-15
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

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 <1.5 times above normal ranges; AST/ALT <1.5 times above normal ranges; creatinine ≥ 1.5 mg/dl. Written informed consent Absence of anypsychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule The patients must be all making radical surgery in the case of positive margine they should make adjuvant radiotherapy.
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) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified