Efficacy and Safety of Oral Kanglaite (KLTc)in Men With Prostate Cancer: Randomized, Dose-Ranging Study of the Effects of KLTc on Prostate Specific Antigen (PSA) Doubling Time Among Men With Rising PSA Levels After Definitive Local Therapy
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