high and very high-risk prostate cancer patients MedDRA version: 9.1 Level: LLT Classification code 10061183
Conditions
Interventions
Trade Name: TAXOTERE
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Docetaxel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Sponsors
AZIENDA OSPEDALIERA OSPEDALE S. SALVATORE
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Histologically proven adenocarcinoma of the prostate 2. Prostate cancer patients with two or more of the following prognostic factors: cT2b or T2c or Gleason Score (GS) = 7 or PSA between 10 and 20 ng/ml 3. Prostate cancer patients with High Risk of Recurrence according to NCCN definition :cT3a or GS = 8-10 or PSA > 20 ng/ml 4. Prostate cancer patients with Very High Risk of Recurrence according to NCCN definition(6- NCCN): cT3b-T4 or patients with multiple adverse factors included into the definition of High Risk 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.cN1 patients 2.Patients with history of prior invasive malignant cancer(s) within the last 5 years except adequately treated or controlled basal cell or squamous cell carcinoma of the skin. 3.Patients with history of previous radiotherapy to the abdomen or pelvis 4.Patients with history of previous chemotherapy (during preceding two years) 5.Uncontrolled diabetes 6.Inflammatory Bowel Diseases (Crohn`s disease, ulcerative colitis), acute diverticulitis, diverticulosis of the sigma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the activity (the 5year-biochemical control rate according to the Houston biochemical relapse definition);Secondary Objective: To determine the tolerability (the safety profile, determination of non dose limiting toxicity);Primary end point(s): the activity (the 5year-biochemical control rate according to the Houston biochemical relapse definition) | — |
Countries
Italy
Outcome results
None listed