Background: It seems that assessment of the efficacy and adverse effects of microrelin as a new agent for treatment of high grade prostate cancer is mandatory.
Goal: Assessment of treatment efficacy and adverse effects of microrelin in patient with prostate cancer
Method: 40 patients with high grade prostate cancer (GS>=8 and PSA>20) and extraprostatic extension who are not suitable for surgery or patients with bone metastases or pelvic lymph node involvement in lymph node biopsy are selected from urology clinic of shahid labbafinejad medical center. We explain the goals and study designation to all patients at the beginning of study and each patient who accept this performance, finally included in this study.This study has been designed using single blind randomized clinical trial. Adverse side effects will be evaluated subjectively monthly by phone interview and objectively using blood analysis every three months. All patients are assessed using prostate examination by digital rectal examination and biochemical evaluation using blood analysis (CBC, Bun, Cr, Ca, P, SGPT, SGOT, Alkp, PSA, FSH, LH, PRL, Estradiol, and testosterone) every three months. All patients with bone metastases will be re-evaluated annually with whole body bone scan.