Safety and Efficacy of Kanglaite Gelcaps in Prostate Cancer



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/30/-0001
Start Date:November 2011

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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


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.


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
We found this trial at
5
sites
Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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Baltimore, Maryland 21231
410-955-6190
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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Baltimore, MD
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201 East Huron Street
Chicago, Illinois 60611
(847) 491-3741
Northwestern University Northwestern is recognized both nationally and internationally for the quality of its educational...
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Chicago, IL
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Evanston, Illinois 60201
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Evanston, IL
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New Brunswick, New Jersey 08901
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New Brunswick, NJ
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