Observational Program to Assess Use of Intermittent Adjuvant Deprivation Therapy With Lucrin Depot in Patients With Advanced Prostate Cancer in Russia

• Duration of induction stage [ Time Frame: Induction therapy is planned at least 6-9 months after visit 1 ] [ Designated as safety issue: No ]
  Time period between first injection of Lucrin Depot and stopping of treatment due to appropriate decrease of prostate specific antigen
  
  
• Number of patients received Lucrin Depot in intermittent adjuvant regimen [ Time Frame: 2 years of observation ] [ Designated as safety issue: No ]
  
• Number of patients continuing taking Lucrin Depot in intermittent adjuvant regimen by the end of program [ Time Frame: 2 years of observation ] [ Designated as safety issue: No ]
  

• Time to onset of hormone-refractory prostate cancer in intermittent adjuvant deprivation subjects [ Time Frame: For a duration of 2 years of observation and 30 days of follow-up period ] [ Designated as safety issue: No ]
  To describe the rates of hormone refractory stage in patients with advanced prostate cancer receiving intermittent hormone monotherapy with Lucrin Depot in Russian Federation during 2 years
  
  
• Duration of treatment-off period in intermittent adjuvant deprivation regimen [ Time Frame: For a duration of 2 years of observation ] [ Designated as safety issue: No ]
  To evaluate median percentage of time off-treatment during 2 years
  
  
• Patients' age [ Time Frame: Demographic information will be collected during first visit at the site ] [ Designated as safety issue: No ]
  
• Patients' race [ Time Frame: Demographic information will be collected during first visit at the site ] [ Designated as safety issue: No ]
  

300 patients with advanced prostate cancer will be enrolled at 33 sites in Russia. The eligible patients will start hormone treatment with Lucrin depot 3.75 mg once every 28 days, subcutaneously or intramuscularly. Duration of induction therapy planned at least 6 months (6-9 months). After prostate specific antigen and testosterone levels are measured every 3 months. When prostate specific antigen decreases by > 90% from baseline (prostate specific antigen should be < 10 ng/ml ) or becomes lower than 4.0ng/ml (for 2 consecutive measurements made at least 2 weeks apart) the patients are included into intermittent hormone therapy group. Patients with prostate specific antigen decrease not achieved > 90% from baseline or down to values of 4.0 ng/ml or lower are withdrawn from the trial: they will receive standard-of-care.

In patients having prostate specific antigen decrease > 90% from baseline (prostate specific antigen should be < 10 ng/ml) or values less than 4.0 ng/ml after 6-9 months of continuous hormone therapy, the therapy is stopped. The patients are followed-up and their prostate specific antigen and testosterone being measured every 4 weeks. If prostate specific antigen becomes ≥ 10.0 ng/ml, hormone therapy is resumed until prostate specific antigen is < 4.0 ng/ml for 2 consecutive measurements made at least 2 weeks apart. Duration of hormonal therapy cycle should be at least 3 months. Then intermitting treatment is performed according to similar scheme. Prostate specific antigen and testosterone are determined each 12 weeks when hormone therapy is administered and each 4 weeks after it has been stopped. The treatment is carried out for 2 years or until hormone refractory prostate cancer develops.

The duration of observation of therapy is carried out for 2 years or until hormone refractory prostate cancer develops.

Treatment patterns in use of Lucrin Depot in intermittent adjuvant regimen, the rates of hormone refractory stage in patients with advanced prostate cancer receiving intermittent hormone monotherapy will be described.