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Safety and Efficacy of Kanglaite Gelcaps in Prostate Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

NCT01483586•KangLaiTe USA

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

MALE

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

Locations (5)

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

Key Dates

Start Date

November 1, 2011

Primary Completion Date

December 1, 2013

Completion Date

December 1, 2013

Last Updated

April 14, 2014

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

kanglaite gelcap

DRUG

Kanglaite gelcap

DRUG

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

NCT05691465

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

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RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 14, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Efficacy of Kanglaite Gelcaps in Prostate Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC