METASTATIC HORMONREFRACTORY PROSTATE CARCINOMA MedDRA version: 9.1 Level: LLT Classification code 10007453
Conditions
Interventions
Trade Name: IPSTYL
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Lanreotide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Sponsors
G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: -Histologically proven prostate adenocarcinoma -Age years: ≥ 18 -Estimated life expectancy of at least 3 months -Performance status =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the pathologic response;Secondary Objective: Evaluation the disease free survival. Evaluation of chemotherapy toxicity. Determination of the overall survival;Primary end point(s): Assessment of the pathologic response | — |
Countries
Italy
Outcome results
None listed