Back to results

Safety and Efficacy of Kanglaite Gelcaps in Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

kanglaite gelcap

Kanglaite gelcap

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Northwestern University
North Shore University
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
The Cancer Institute of New Jersey
Duke University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

KLTc high dose

KLTc low dose

Arm Description

6 KLTc gelcaps taken four times a day

3 KLTc gelcaps taken four times a day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

PSA objective response

a 50% or more decline in PSA level compared to baseline

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

Full Information

NCT ID

NCT01483586

First Posted

November 28, 2011

Last Updated

April 11, 2014

Sponsor

KangLaiTe USA

1. Study Identification

Unique Protocol Identification Number

NCT01483586

Brief Title

Safety and Efficacy of Kanglaite Gelcaps in Prostate Cancer

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 Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Terminated

Why Stopped

Sponsor decision

Study Start Date

November 2011 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

KangLaiTe USA

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

KLTc high dose

Arm Type

Experimental

Arm Description

6 KLTc gelcaps taken four times a day

Arm Title

KLTc low dose

Arm Type

Experimental

Arm Description

3 KLTc gelcaps taken four times a day

Intervention Type

Drug

Intervention Name(s)

kanglaite gelcap

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Kanglaite gelcap

Intervention Description

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

Primary Outcome Measure Information:

Title

prostate specific antigen doubling time (PSADT)

Description

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

Time Frame

over 12 months on study drug

Secondary Outcome Measure Information:

Title

PSA objective response

Description

a 50% or more decline in PSA level compared to baseline

Time Frame

over 12 months on study drug

Title

KLTc intake compliance

Description

actual number of capsules taken divided by the expected number of capsules taken multiplied by 100 to get a percentage of compliance

Time Frame

each month, up to 12 months on study drug

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

North Shore University

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

Country

United States

Facility Name

The Cancer Institute of New Jersey

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08901

Country

United States

Facility Name

Duke University

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Kanglaite Gelcaps in Prostate Cancer

We'll reach out to this number within 24 hrs