high risk locally advanced prostate cancer MedDRA version: 9.1 Level: LLT Classification code 10060862 Term: Prostate cancer
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: 80-
Sponsors
ISTITUTI FISIOTERAPICI OSPITALIERI
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Histological diagnosis of prostate adenocarcinoma Locally advanced disease with at least two of the following criteria: -Gleason Score >6 -PSA : 10-40 ng/mL ->T2b N0M0 -Biopsy fragments positive for cancer ( > 50% della loro lunghezza) in both prostate lobes No distant metastases 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: No peripheral neuropathy No uncontrolled infection No uncontrolled diabetes mellitus No previous pelvic irradiation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Feasibility in terms of activity and tolerability of docetaxel weekly administered in neoadjuvant and rt-concomitant setting in high risk locally advanced prostate cancer;Secondary Objective: progression free survival time to prostate-specific antigen failure local control identification of genes as tumor response markers quality of life;Primary end point(s): Early and late toxicity measured with the EORTC/RTOG scale Biochemical, clinical and histological progression free survival | — |
Countries
Italy
Outcome results
None listed