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NCT Number: NCT07728474

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

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.

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Key information

Conditions

Non-muscle Invasive Bladder Cancer (NMIBC) Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • Inability to provide informed consent.
  • Inability to swallow tablets (esophageal stricture, feeding through gastrostomy).
  • Ineligibility for SOC therapy such as BCG instillations (where appropriate).
  • Upper tract urothelial carcinoma within the past 2 years.
  • Any malignancy other than NMIBC, active or systemically treated within the past 2 years (not including localized cutaneous basal cell or squamous cell carcinoma).
  • Estimated life expectancy < 5 years.
  • Pregnant women, and women planning future pregnancy or wishing to preserve fertility.
  • Investigator evaluation of a physical or mental condition limiting a patient's ability to participate in the study.

Treatment and study plan

LCS103

Dietary Supplement

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.

Primary outcomes

  1. LCS103 Safety: Incidence and Severity of Treatment-Emergent Adverse Events, Graded by CTCAE v5.0

    Time frame: During the 1-year LCS103 administration period.

    Incidence and severity of treatment-associated adverse events according to CTCAE v5.0 grading system.

Secondary outcomes

  1. Percentage of Prescribed LCS103 Tablets Consumed, Based on Pill Count

    Time frame: During the 1-year study administration period

    Adherence assessed by LCS103 tablet count at months 3, 6, 9, and 12 (investigational arm only). Adherence percentage calculated as (expected tablets consumed - tablets remaining in returned bottles) / expected tablets consumed × 100, where expected consumption is based on the prescribed dose of 6 tablets/day. Adherence ≥75% is classified as adequate.

  2. Bladder cancer recurrence at 1 year

    Time frame: During the 1-year study administration period

    Bladder cancer recurrence at 1 year, defined as suspicious cystoscopic findings, malignant cells in urine cytology, or positive bladder biopsy.

  3. Bladder cancer stage or grade progression at 1 year

    Time frame: Baseline to the end of the 1-year study follow-up period

  4. Change in urinary symptom severity (IPSS)

    Time frame: Baseline to the end of the 1-year study follow-up period

    Urination symptom severity is assessed by the International Prostate Symptom Score (IPSS).

    Unit of Measure: Units on a scale (IPSS total symptom score) Minimum value: 0 Maximum value: 35 Score direction: Higher scores indicate worse urinary symptoms

  5. Change in overall health-related quality of life (EQ-5D-5L/EQ-VAS)

    Time frame: Baseline to the end of the 1-year study follow-up period

    Health-related quality of life is assessed by the EQ-VAS component of the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).

    Unit of Measure: Score on the EQ-VAS (self-rated current health) Minimum value: 0 Maximum value: 100 Score direction: Higher scores indicate better self-rated health

  6. Change in erectile function - male participants only (IIEF-EF)

    Time frame: Baseline to the end of the 1-year study follow-up period

    Erectile function in male participants is assessed by the Erectile Function domain of the International Index of Erectile Function questionnaire (IIEF-EF). Female participants are not assessed.

    Unit of Measure: Units on a scale (IIEF-EF domain score) Minimum value: 1 Maximum value: 30 Score direction: Higher scores indicate better erectile function

  7. Change in serum C-reactive protein (CRP)

    Time frame: Baseline to the end of the 1-year study follow-up period

    Serum C-reactive protein (CRP) concentration is measured on routine blood chemistry.

    Unit of Measure: mg/dL Range: 0-0.5

  8. Change in neutrophil-to-lymphocyte ratio (NLR)

    Time frame: Baseline to the end of the 1-year study follow-up period

    Neutrophil-to-lymphocyte ratio (NLR) is calculated from the complete blood count (absolute neutrophils divided by absolute lymphocytes).

    Unit of Measure: Ration

  9. Change in urinary leucocyte count (leucocyturia)

    Time frame: Baseline to the end of the 1-year study follow-up period

    Urinary leucocyte count is measured on routine urinalysis. Unit of Measure: Leu/µL Range: Negative, 25 Leu/µL

  10. Change in tongue appearance - a common measure of inflammation in traditional Chinese medicine.

    Time frame: Baseline to the end of the 1-year study follow-up period

    Change in tongue appearance assessed from standardized digital photographs of the tongue, taken at baseline and at the end of the study.

    Unit of Measure: Photographic comparison

  11. Change in maximum urinary flow rate (Qmax) - from uroflowmetry.

    Time frame: Baseline to the end of the 1-year study follow-up period

    Maximum urinary flow rate (Qmax) measured by uroflowmetry. Unit of Measure: Millilitres per second (mL/s)

Study contacts

Contact information is provided by the study sponsor or research team.

Yair Maimon, Dr.

CONTACT

[email protected]

+972-3-5043030

Sponsors and collaborators

Lead sponsor

LifeBiotic Medical Research Ltd.

Industry

Registry information

Official study title

LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder - Phase IIA Randomized Controlled Trial

Acronym: LCS103

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 27, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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