Decitabine Dacogen of degarelix was as a single SC 4 Ml injections on days

Goserelin monthly for 12 weeks. For Decitabine Dacogen patients in the degarelix treatment group, an initial dose of 240 mg degarelix on day 0 as two 3-ml injections injected deep into the subcutaneous adipose tissue of the abdominal wall. The second and third dose of 80 mg of degarelix was as a single SC 4 Ml injections on days 28 and 56 administered. For patients in the control group, the implants were placed subcutaneously in the abdominal wall introduced goserelin every 28 days. On day 0, patients were new in the goserelin arm U treatment with 50 mg once-t Possible with oral bicalutamide for FL w are continuous protection Fi during the entire duration of RST dosage for 28 days. The initial evaluation of patients included collection of demographic data, medical history, medications, vital signs, ECG, the Europ Pean Union Cooperative Oncology Group performance score, and history of prostate cancer confinement Lich time since diagnosis stage, TNM and Gleason score. Blood and urine were also collected to assess reference values for untreated Ver Changes in effi ciency and safety to establish important variables. Total prostate volume was measured locally by transrectal ultrasound equipment needed, the process of a unified and user-friendly 鈥 is out S manual for each location. The severity and development of LUTS w Were during the treatment by questionnaires GEN International Prostate Symptom Score as assessed in earlier Used hnlichen studies. Mild LUTS IPSS was defined ned by 1 July, moderate LUTS IPSS of 8 as serious as IPSS 19 and 20 35th Beneficial for patients with clinical moderate / severe were also those who have a base 13, a threshold h Ufigsten used IPSS in LUTS studies have examined. A clinically significant response was defined as a ned Change in the IPSS of at least three basis points. The quality of life T in terms of symptoms was assessed by urine, the eighth IPSS question separately. Patients were asked to indicate their status on a scale of 0 to 6. Happy / satisfied, above all satisfied / mixed / mostly dissatisfi ED, and unhappy / terrible: gear changes were studied in three areas. The impact of the symptoms My urine was benign in various fields of health and of the impact factor of prostatic hyperplasia, assessed a self-administered questionnaire. Each of these variables were monitored on a monthly basis. Blood samples for analysis of testosterone and PSA were collected at each monthly visit before drug administration. Testosterone was measured by a validated liquid chromatography system with tandem mass spectrometry assay for Ferring Pharmaceuticals A / S measured the PSA level was measured by a chemiluminescence method validated by a central laboratory. Phone start-up estimates And safety reps Possibility of laboratory values, including normal clinical variables. A laboratory analysis of all clinical variables global central analytical chemistry, H Hematology and urine for safety in the laboratory. The investigator or delegated Adorned rztlichen qualified evaluated the clinical significance of ECG Cancer. The most important ma Exception effectiveness effectiveness was the average percent reduction of POS based on the 12th Week. In those who had not completed the entire study, the last observation carried forward approach was used to impute values at week 12. Were changes of covariance with baseline IPSS score and analyze POS as a covariate and treatment arm.

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