Clinical trial NCT01483586: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: KangLaiTe USA
Sponsor class: INDUSTRY
First posted: 2011-12-01
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: prostate specific antigen doubling time (PSADT)
timeFrame: over 12 months on study drug
Secondary outcomes:
measure: PSA objective response
timeFrame: over 12 months on study drug
measure: KLTc intake compliance
timeFrame: each month, up to 12 months on study drug
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Evanston
country: United States
facility: North Shore University
state: Illinois
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: New Brunswick
country: United States
facility: The Cancer Institute of New Jersey
state: New Jersey
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
References: