Safety and Efficacy of Kanglaite Gelcaps in Prostate Cancer

Inclusion Criteria:

• confirmed adenocarcinoma of the prostate
• undergone definitive treatment (surgery, surgery with radiation therapy, cryotherapy, radiation therapy or brachytherapy) for the primary prostate tumor with a rising PSA
• life expectancy greater than 6 months
• has Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
• use of other dietary/herbal supplements (e.g. saw palmetto, selenium, etc.) has been stable for at least 2 months prior to screening and the patient agrees not to stop or change the dose while participating in the study.
• Adequate hepatic function with serum bilirubin ≤ 1.5 times the upper institutional limits of normal, ALT and AST ≤ 2.5 times the upper institutional limits of normal
• Adequate renal function with serum creatinine ≤ 1.5 times the upper institutional limits of normal
• Adequate hematologic function (absolute neutrophil counts ≥ 1,500 mm3 and platelets ≥ 100,000 mm3)
• All electrolytes (including potassium, sodium, and serum or ionized calcium) must be within normal limits

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