Safety and Efficacy of Kanglaite Gelcaps in Prostate Cancer

NCT ID: NCT01483586

Last Updated: 2014-04-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-12-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KLTc high dose

6 KLTc gelcaps taken four times a day

Group Type: EXPERIMENTAL

Kanglaite gelcap

Intervention Type: DRUG

6 KLTc gelcaps taken four times a day throughout the study (12 months). Each gelcap contains .45g KLT

KLTc low dose

3 KLTc gelcaps taken four times a day

Group Type: EXPERIMENTAL

kanglaite gelcap

Intervention Type: DRUG

3 KLTc gelcap capsules four times a day throughout the study (12 months). Each gelcap contains .45g KLT per capsule

Interventions

kanglaite gelcap

3 KLTc gelcap capsules four times a day throughout the study (12 months). Each gelcap contains .45g KLT per capsule

Intervention Type: DRUG

Kanglaite gelcap

6 KLTc gelcaps taken four times a day throughout the study (12 months). Each gelcap contains .45g KLT

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

KangLaiTe USA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Northwestern University

Chicago, Illinois, United States

North Shore University

Evanston, Illinois, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

The Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Duke University

Durham, North Carolina, United States

Countries

United States

Other Identifiers

C10-069

Identifier Type: -

Identifier Source: org_study_id