LCS103 Herbal Tablets to Help Prevent Return of Non-Muscle Invasive Bladder Cancer
Tests LCS103 herbal tablets alongside usual care in adults with non-muscle invasive bladder cancer.
Plain-language title generated from the registry record
Registry title: LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder
Key facts
- Where
- Haifa, IsraelSee the site
Where in Israel
- Rambam Health Care Campus, Urology DepartmentHaifa, IsraelTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- LifeBiotic Medical Research Ltd.
- Trial code
- NCT07728474
- Record updated
- 29 July 2026
- Original description
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.Read full original descriptionShow less
LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder - Phase IIA Randomized Controlled Trial
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.
Inclusion: Men and women aged ≥ 18 years; Non-muscle invasive urothelial carcinoma, histologically confirmed by TURBT procedure within 3 months before enrollment; Complete resection of bladder tumor in recent TURBT.
Exclusion: Ineligibility for SOC therapy such as BCG instillations (where appropriate); Any malignancy other than NMIBC, active or systemically treated within the past 2 years (not including localized cutaneous basal cell or squamous cell carcinoma); Investigator evaluation of a physical or mental condition limiting a patient's ability to participate in the study; Estimated life expectancy < 5 years; Inability to provide informed consent; Inability to swallow tablets (esophageal stricture, feeding through gastrostomy); Upper tract urothelial carcinoma within the past 2 years; Pregnant women, and women planning future pregnancy or wishing to preserve fertility.