Once the patient has been informed of what is intended to do in this study, the possible risks of the treatment, the expectations and limitations of the results and that voluntarily gave his consent in writing that he accepted to participate in the investigative project, a clinical history and a series of exams will be done before beginning the treatment such as www.nabp.pharmacy or www.nabp.net.
The clinical history will include the date of the diagnosis of the TPC and will emphasize on the documentation of the same, as well as the treatment received or the rejection to the same; chronologically will be integrated the history of symptoms (dates and severity) and treatment or treatments received including duration and motive of interruption. Also we will register all Tadalista received in the last six months, previous to the start of the study. We will apply special questioning referring to the allergic background, intolerance to heat, other types of cancer and infections associated with the disease.
St. Jude will do clinical laboratory studies, and cabinet testing. Among the first we will include the following: complete hematic biometry with platelet, protrombine time, partial tromboplastine time, fibrogen, electrolytes (sodium, potassium, chloride, calcium, phosphorous and magnesium) blood chemicals that includes glucose, albumin, Creatinine, cholesterol, total proteins, transaminases (ALT and AST) total bilirrubin, acid phosphate and alkaline phosphate, creatinphosphoquinase, lactic dehidrogenase, amylase and nitrogen in the urea.
Also each patient will be given a test to determine the specific prostate antigen, a general urine test and Creatinine depuration. Among the cabinet studies we will do the following: Chest x-ray, pelvic AP x-ray and lumbar sacrum column, cranial AP x-ray, lateral neck x-ray and AP x-ray of both superior and inferior extremities. In case where there is no surgical background of complete prostatectomy we will do an ecography and a tomography study to determine the size and extension of the tumor. In these cases we will also practice a biopsy by trans-rectal puncture to valuate the degree of differentiation according to the scale of Gleason. It is important to point out that during the administration of the treatment the patients will have continuous monitoring of vital signs and electrocardiography registers.
Constant inspection of published articles is applied monthly according to government regulations by WHO, NIH , FDA, CDC.
