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

NCT07728474 | Recruiting

• 1 other identifier: 0424-24-RMB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

NMIBC; Bladder Cancer; Non-Muscle Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

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

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

  During the 1-year LCS103 administration period.

Secondary Outcomes (11)

• Percentage of Prescribed LCS103 Tablets Consumed, Based on Pill Count

  During the 1-year study administration period

• Bladder cancer recurrence at 1 year

  During the 1-year study administration period

• Bladder cancer stage or grade progression at 1 year

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

• Change in urinary symptom severity (IPSS)

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

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

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

Study Arms (2)

LCS103 + Standard of Care

EXPERIMENTAL

Patients in the investigational arm will receive 1-year bidaily 3 oral tablets of LCS103 herbal formula, in addition to the SOC recommended per risk group

Dietary Supplement: LCS103

Standard of Care Alone

NO INTERVENTION

Participants in the control arm will receive SOC-recommended treatment according to risk group

Interventions

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.

LCS103 + Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LifeBiotic Medical Research Ltd.: lead

Study Sites (1)

Rambam Health Care Campus, Urology Department

Haifa, Israel

RECRUITING

Related Publications (7)

• Maimon Y, Amiel G, Cohen Z, Hoffman A, Samuels N. Prevention of Bladder Cancer Recurrence With the Botanical Formula LCS103: A Case Series Study. Integr Cancer Ther. 2024 Jan-Dec;23:15347354241233233. doi: 10.1177/15347354241233233.

  PMID: 38362870 BACKGROUND

• Maimon Y, Samuels N, Cohen Z, Berger R, Rosenthal DS. Botanical Formula LCS101: A Multi-Targeted Approach to Cancer Care. Integr Cancer Ther. 2018 Dec;17(4):1020-1026. doi: 10.1177/1534735418801528. Epub 2018 Oct 10.

  PMID: 30303021 BACKGROUND

• Cragg GM, Newman DJ. Plants as a source of anti-cancer agents. J Ethnopharmacol. 2005 Aug 22;100(1-2):72-9. doi: 10.1016/j.jep.2005.05.011.

  PMID: 16009521 BACKGROUND

• Yates JS, Mustian KM, Morrow GR, Gillies LJ, Padmanaban D, Atkins JN, Issell B, Kirshner JJ, Colman LK. Prevalence of complementary and alternative medicine use in cancer patients during treatment. Support Care Cancer. 2005 Oct;13(10):806-11. doi: 10.1007/s00520-004-0770-7. Epub 2005 Feb 15.

  PMID: 15711946 BACKGROUND

• Antoni S, Ferlay J, Soerjomataram I, Znaor A, Jemal A, Bray F. Bladder Cancer Incidence and Mortality: A Global Overview and Recent Trends. Eur Urol. 2017 Jan;71(1):96-108. doi: 10.1016/j.eururo.2016.06.010. Epub 2016 Jun 28.

  PMID: 27370177 BACKGROUND

• Matulewicz RS, Steinberg GD. Non-muscle-invasive Bladder Cancer: Overview and Contemporary Treatment Landscape of Neoadjuvant Chemoablative Therapies. Rev Urol. 2020;22(2):43-51.

  PMID: 32760227 BACKGROUND

• Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.

  PMID: 36633525 BACKGROUND

Related Links

• NCI SEER, Cancer Stat Facts: Bladder Cancer
• American Cancer Society, Intravesical Therapy for Bladder Cancer

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Etan Eigner, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yair Maimon, Dr.

CONTACT

+972-3-5043030; yair@tcm.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, parallel-assignment, open-label trial. Participants will be randomized in a 1:1 ratio to either the investigational (LCS103) or control arm (Standard of Care), with randomization stratified by EAU risk group (low, intermediate, and high risk).

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 27, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: The IPD will be available beginning 12 months after publication of the primary study results, for 5 years following publication of the primary study results.
• Access Criteria: Data will be available upon reasonable request to the Sponsor, LifeBiotic Medical Research Ltd., following review and approval of a research proposal and execution of a data-sharing agreement.

Locations

IL (1)