Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
The University of Texas Health Science Center, Houston
This is an open-label, single-arm study of neoadjuvant ADT and chemotherapy in subjects with non-metastatic, locally-advanced prostate cancer who are eligible for radical prostatectomy. Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy. Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. The primary endpoint will be complete or near-complete pathologic response. Safety will be assessed on any patient receiving at least one dose of study drug by the reporting of adverse events, vital signs and by the assessment of findings on physical exam and routine safety laboratory determinations. The severity of adverse events and certain abnormal laboratory findings will be assessed according to the NCI CTCAE V4.03. Laboratory-based studies will evaluate the following: * Complete metabolic profile o BUN, creatinine, alkaline phosphatase, ALT/AST, total bilirubin, LDH, calcium, albumin, glucose, magnesium, uric acid, phosphorous * Electrolytes o Sodium, potassium, chloride, CO2 content * Hematology * CBC with differential, platelet count * PT, INR, PTT * Testosterone * Biomarkers * PSA * CTCs
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
