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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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

prostate specific antigen doubling time (PSADT)

Outcome 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

Outcome Time Frame:

over 12 months on study drug

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

C10-069

NCT ID:

NCT01483586

Start Date:

November 2011

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Duke UniversityDurham, North Carolina  27710
Northwestern UniversityChicago, Illinois  60611
The Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
North Shore UniversityEvanston, Illinois  60201