Terapia di II linea con Docetaxel + Lanreotide in pazienti con carcinoma prostatico metastatico ormonorefrattario e in progressione in corso di chemioterapia di I linea con Docetaxel. Studio di fase II. - RESTORE

• Conditions: METASTATIC HORMONREFRACTORY PROSTATE CARCINOMA; MedDRA version: 9.1Level: LLTClassification code 10007453

• Registration Number: EUCTR2009-017596-26-IT
• Lead Sponsor: G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-01
• 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
-Age years: ≥ 18
-Estimated life expectancy of at least 3 months
-Performance status < 2
-Adeguate bone marrow (neutrophyles count ≥ 1,500/mm3; platelets ≥ 100,000/mm3; haemoglobin ≥ 10 g/dL), renal and liver function.
-Evidence of metastatic hormone-refractory prostate cancer, with adeguate testoterone suppression and progressive disease under Docetaxel treatment.
-Serological progression (i.e. two consecutive PSA determinations at minimum two weeks interval, showing a 25% increase compared to the lower level observed during chemotherapy or disease progression confirmed by CT scan or MRI.
-Normal ranges of Cromogranina A [20 98 ng/ml].
-Patient compliance.
-Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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

-Histological and/or serological (CgA) diagnosis of neuroendocrine tumor (prostatic and extra-prostatic); other concomitant neoplasms (except basal cell carcinoma).
-Chronic PPI therapy.
-Renal impairment.
-Uncontrolled arterial hypertension.
-Parkinsons disease.
-Peripheral neuropathy grade>2 (NCI-CTC versione 3.0).
-Uncontrolled active infections.
-Active peptic ulcer, uncontrolled Diabetes mellitus or other controindications to the cortisonic therapy.
-Myocardial infarction (within 12 mounths before written informed consent), uncontrolled angina or uncontrolled cardiac arrhythmia.
-Other ongoing antitumoral treatments.
-Concomitant enrollment in other Clinical Studies.
-Known allergic reactions to study drugs.
-Neurological and /or psychiatrical symptoms.
-Any other severe clinical condition that, by Investigators evaluation, produced an unjustified risk for the patient and be interferring with the study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Assessment of the pathologic response;Secondary Objective: Evaluation the disease free survival.<br><br>Evaluation of chemotherapy toxicity.<br><br>Determination of the overall survival;Primary end point(s): Assessment of the pathologic response