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Safety and Efficacy of Kanglaite Gelcaps in Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01483586
Recruitment Status : Terminated (Sponsor decision)
First Posted : December 1, 2011
Last Update Posted : April 14, 2014
Information provided by (Responsible Party):
KangLaiTe USA

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: kanglaite gelcap Drug: Kanglaite gelcap Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: KLTc high dose
6 KLTc gelcaps taken four times a day
Drug: Kanglaite gelcap
6 KLTc gelcaps taken four times a day throughout the study (12 months). Each gelcap contains .45g KLT

Experimental: KLTc low dose
3 KLTc gelcaps taken four times a day
Drug: kanglaite gelcap
3 KLTc gelcap capsules four times a day throughout the study (12 months). Each gelcap contains .45g KLT per capsule

Primary Outcome Measures :
  1. prostate specific antigen doubling time (PSADT) [ Time Frame: over 12 months on study drug ]
    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

Secondary Outcome Measures :
  1. PSA objective response [ Time Frame: over 12 months on study drug ]
    a 50% or more decline in PSA level compared to baseline

  2. KLTc intake compliance [ Time Frame: each month, up to 12 months on study drug ]
    actual number of capsules taken divided by the expected number of capsules taken multiplied by 100 to get a percentage of compliance

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01483586

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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
North Shore University
Evanston, Illinois, United States, 60201
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, New Jersey
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
KangLaiTe USA
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Responsible Party: KangLaiTe USA Identifier: NCT01483586    
Other Study ID Numbers: C10-069
First Posted: December 1, 2011    Key Record Dates
Last Update Posted: April 14, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases