Prostate Cancer
Conditions
Brief summary
Following radical prostatectomy (RP), about 20% to 40% of the patients with prostate cancer (PCa) exhibit pathological parameters which are associated with a high risk of disease recurrence. The rationale for NHT is based on the theory that androgen ablation induces PCa apoptosis which induces a regression of the primary tumor bulk before RP. However the use of NHT prior RP is highly controversial. In spite of these unenthusiastic results, the relative short time of treatment and the use of different drugs from those utilized in other trials might still to make this regimen attractive in terms of drug related side effects and effectiveness. In this regard, Bicalutamide presents unique characteristics since it work differently respect to other anti-hormonal agents by interfering on both genotropic and non-genotropic mechanisms of androgen receptor
Interventions
DRUGBicalutamide
Sponsors
University of L'Aquila
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with cT2-T3a prostate cancer
Exclusion criteria
* Men\>75 years * Men\<18 years * Prior hormonal therapy * Prior radiation or chemotherapy * Prior investigational agents * Life expectancy \> 10 years * Prior malignancy within the last five years * Any other serious medical or psychiatric condition
Countries
Italy
Outcome results
None listed