Safety and Efficacy of Kanglaite Gelcaps in Prostate Cancer

Study Overview
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Brief Summary
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This research is being done to evaluate the safety and efficacy of the investigational Kanglaite gelcap (KLTc) on PSA in men with prostate cancer when given for twelve months.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: kanglaite gelcap
* Drug: Kanglaite gelcap


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KLTc high dose<br>6 KLTc gelcaps taken four times a day | Drug: Kanglaite gelcap<br>* 6 KLTc gelcaps taken four times a day throughout the study (12 months). Each gelcap contains .45g KLT<br>|
| Experimental: KLTc low dose<br>3 KLTc gelcaps taken four times a day | Drug: kanglaite gelcap<br>* 3 KLTc gelcap capsules four times a day throughout the study (12 months). Each gelcap contains .45g KLT per capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prostate specific antigen doubling time (PSADT) | PSADT is defined as the natural log of 2 (0.693)divided by the slope (beta- rate of change) of the relationship between the log of PSA and the time of PSA measurement using linear regression model | over 12 months on study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA objective response | a 50% or more decline in PSA level compared to baseline | over 12 months on study drug | 
| KLTc intake compliance | actual number of capsules taken divided by the expected number of capsules taken multiplied by 100 to get a percentage of compliance | each month, up to 12 months on study drug |