Trial Information

Prospective, Multi-Center, Observational Program to Assess Routine Use of Intermittent Adjuvant Deprivation Therapy With Lucrin Depot in Patients With Advanced Prostate Cancer in the Russian Federation

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from baseline or down to values of 4.0 ng/ml or lower are withdrawn from the trial: they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.