Clinical trial · Interventional
Safety and Efficacy of Kanglaite Gelcaps in Prostate Cancer
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
NCT01483586CI-TRIAL-00014254terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| kanglaite gelcap | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- KLTc high dose
- description
- 6 KLTc gelcaps taken four times a day
- interventionNames
- Drug: Kanglaite gelcap
- type
- EXPERIMENTAL
- label
- KLTc low dose
- description
- 3 KLTc gelcaps taken four times a day
- interventionNames
- Drug: kanglaite gelcap
Primary outcomes (1)
- measure
- prostate specific antigen doubling time (PSADT)
- timeFrame
- over 12 months on study drug
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.