Safety and Efficacy of Kanglaite Gelcaps in Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01483586
• Other study ID #: C10-069
• Status: Terminated
• Phase: Phase 2
• First received: November 28, 2011
• Last updated: April 11, 2014
• Start date: November 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: KangLaiTe USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Northwestern University	Chicago	Illinois
United States	Duke University	Durham	North Carolina
United States	North Shore University	Evanston	Illinois
United States	The Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
KangLaiTe USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	PSA objective response	a 50% or more decline in PSA level compared to baseline	over 12 months on study drug	No
Secondary	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	No