Safety and Efficacy of Kanglaite Gelcaps in Prostate Cancer

This study has been terminated.
(Sponsor decision)
Sponsor:
Information provided by (Responsible Party):
KangLaiTe USA
ClinicalTrials.gov Identifier:
NCT01483586
First received: November 28, 2011
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: kanglaite gelcap
Drug: Kanglaite gelcap
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by KangLaiTe USA:

Primary Outcome Measures:
  • prostate specific antigen doubling time (PSADT) [ Time Frame: over 12 months on study drug ] [ Designated as safety issue: No ]
    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:
  • PSA objective response [ Time Frame: over 12 months on study drug ] [ Designated as safety issue: No ]
    a 50% or more decline in PSA level compared to baseline

  • KLTc intake compliance [ Time Frame: each month, up to 12 months on study drug ] [ Designated as safety issue: No ]
    actual number of capsules taken divided by the expected number of capsules taken multiplied by 100 to get a percentage of compliance


Enrollment: 90
Study Start Date: November 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483586

Locations
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
  More Information

No publications provided

Responsible Party: KangLaiTe USA
ClinicalTrials.gov Identifier: NCT01483586     History of Changes
Other Study ID Numbers: C10-069
Study First Received: November 28, 2011
Last Updated: April 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 14, 2014