Advanced prostate cancer MedDRA version: 9.1 Level: HLT Classification code 10036966 Term: Prostatic neoplasms and hypertrophy
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Docetaxel
Concentration type: equal
Trade Name: ZOMETA
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Zoledronic acid
C
Sponsors
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Prostate adenocarcinoma -Metastatic disease "ab initio" or neoplasic disease after loco-regional therapy -Bone metastase -Age > 18 -ECOG P.S=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Previous hormonal therapy except for less than 6 months treatment -previous difosphonate treatment -Concomitant serious disease (cardiovascular, hepathic, renal) -Second neoplasia (except for skin basalioma) -Peripheric neuropatia >/= 2 -brain metastases -mental disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Progression free survival;Secondary Objective: Survival, Tollerability, adverse event, quality of life, pain, scheletal related event, biological endpoint;Primary end point(s): Progression free survival | — |
Countries
Italy
Outcome results
None listed