Safety and Efficacy of Kanglaite Gelcaps in Prostate Cancer

Exclusion Criteria

• •Patients with evidence of metastatic disease would be excluded, except for presence of positive lymph nodes from the surgical pathology. Similarly, patients with radiological evidence of lymph nodes \< 2 cm that lack pathological confirmation would be eligible
• •Patients with a PSA doubling time of \<6months at screening would be excluded
• •Patients meeting Phoenix criteria for biochemical failure (nadir + ≥2ng/mL increase in serum PSA) who wish additional conventional therapy
• •Any concurrent malignancy other than adequately treated basal or squamous cell skin cancer or superficial bladder cancer
• •Any psychiatric or other disorders such as dementia that would prohibit the patient from understanding or rendering informed consent or from fully complying with protocol treatment and follow-up
• •Inability to swallow capsules
• •Patients with a known history of gastrointestinal disease, surgery or malabsorption that could potentially impact the absorption of the study drug
• •Patients requiring the use of a feeding tube
• •Receipt of prior chemotherapy