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LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder

NCT07728474 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-29

No results posted yet for this study

Summary

This study is a phase IIA, single-site, randomized, controlled, open-label clinical trial evaluating the safety and efficacy of the LCS103 oral herbal formula for the secondary prevention of NMIBC. The study will include 60 participants randomized 1:1 to either the investigational or control arm.

Patients in the investigational arm will receive three oral tablets of LCS103 herbal formula twice daily for 1 year, in addition to the SOC recommended per risk group:

* Low Risk: Cystoscopic follow-up at 3 \& 9 months and yearly thereafter.
* Intermediate Risk: 1-year intravesical instillations of BCG. Cystoscopic follow-up at 3 \& 9 months, then biannually for 2 years and yearly thereafter.
* High Risk: 3-year intravesical instillations of BCG. Cystoscopy and urine cytology every 3 months for 2 years, then biannually thereafter.

Participants in the control arm will receive SOC treatment as mentioned above. After 1 year, the investigational treatment will be stopped, and all participants will continue SOC treatment and surveillance.

The enrollment period is expected to be 1 year. The study will be terminated after the final visit of the last patient. The total study duration is expected to be 2 years.

Conditions

  • Non-muscle Invasive Bladder Cancer (NMIBC)

Interventions

DIETARY_SUPPLEMENT

LCS103

LCS103 is an oral botanical dietary supplement composed of multiple herbal extracts. Participants in the investigational arm will receive 3 tablets twice daily for 12 months in addition to the standard of care according to the EAU risk group.

Sponsors & Collaborators

  • LifeBiotic Medical Research Ltd.

    lead INDUSTRY

Principal Investigators

  • Etan Eigner, MD · Rambam Health Care Campus

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-07-31
Completion
2028-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07728474 on ClinicalTrials.gov