Efficacy and Safety of oral Kanglaite (KLTc) Gelcap in Men with Prostate Cancer: Randomized, Dose-Ranging Study of the Effects of KLTc Gelcap (3 or 6 capsules four times/day) on Prostate Specific Antigen (PSA) Doubling Time Among Men with Rising PSA Levels after Definitive Local Therapy for Prostate Cancer
To evaluate the effects and safety of two different doses (3 or 6 capsules, four times daily) of KanglaiTe gel capsules on prostate specific antigen doubling time in men with rising PSA after initial local therapy for localized prostate cancer during 12 months of study period.
Men with rising PSA, who have undergone defnitive treatment (surgery, surgery with radiation, cryotherapy, radiation alone or brachytherapy) for the primary tumor and has a rising PSA at two time points each at least 1 week apart, higher then the previous reference value noted within 1 year of study entry. Patients with evidence of metastatic disease are not eligible, with the exception of positive lymph nodes at time of surgery or those less than 2cm that lack pathological confirmation would be eligible. Patient's with testosterone level greater than 150ng/mL at screening, age greater than 18 years old. Good ECOG Performace status 0,1,2. Use of herbal or dietary supplements must be stable 2 months prior to screening and the patient agrees to not stop or change the dose while on study. Adequate hepatic and renal function and normal electrolyte levels.
Patients will come in for a screening visit with their physican for physical exam, obtain routine bloodwork. They will ranzomized to take the KangLaiTe gel capsule 3 capsules four times a day or 6 capsules by mouth 4 times a day. They will present to the clinic for evaluation every month and their PSA will be checked every 3 months. The study length is 12 months in duration.
05/25/2013 04:02 AM