Non-muscle Invasive Bladder Cancer (NMIBC)LCS103NCT07728474
LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder
A study testing LCS103 in people with Non-muscle Invasive Bladder Cancer (NMIBC), run by LifeBiotic Medical Research Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-muscle Invasive Bladder Cancer (NMIBC)
- What is being tested?
- LCS103
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Rambam Health Care Campus, Urology Department
Haifa
Etan Eigner, Dr., +972-4-7771799, E_EIGNER@rambam.health.gov.il
About this study
Official title: 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:
Read more
- 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.
- Being tested
- LCS103
- Keywords
- NMIBC, Bladder Cancer, Non-Muscle Invasive Bladder Cancer
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCS103Dietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: LCS103 |
| Standard of Care Alone | No intervention | Participants in the control arm will receive SOC-recommended treatment according to risk group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the 1-year LCS103 administration period.
Secondary outcomes (11)
Percentage of Prescribed LCS103 Tablets Consumed, Based on Pill Count
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.
Measured: During the 1-year study administration period
Bladder cancer recurrence at 1 year
Bladder cancer recurrence at 1 year, defined as suspicious cystoscopic findings, malignant cells in urine cytology, or positive bladder biopsy.
Measured: During the 1-year study administration period
Bladder cancer stage or grade progression at 1 year
Measured: Baseline to the end of the 1-year study follow-up period
Change in urinary symptom severity (IPSS)
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
Measured: 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)
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
Measured: Baseline to the end of the 1-year study follow-up period
Change in erectile function - male participants only (IIEF-EF)
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
Measured: Baseline to the end of the 1-year study follow-up period
Change in serum C-reactive protein (CRP)
Serum C-reactive protein (CRP) concentration is measured on routine blood chemistry.
Unit of Measure: mg/dL Range: 0-0.5
Measured: Baseline to the end of the 1-year study follow-up period
Change in neutrophil-to-lymphocyte ratio (NLR)
Neutrophil-to-lymphocyte ratio (NLR) is calculated from the complete blood count (absolute neutrophils divided by absolute lymphocytes).
Unit of Measure: Ration
Measured: Baseline to the end of the 1-year study follow-up period
Change in urinary leucocyte count (leucocyturia)
Urinary leucocyte count is measured on routine urinalysis. Unit of Measure: Leu/µL Range: Negative, 25 Leu/µL
Measured: Baseline to the end of the 1-year study follow-up period
Change in tongue appearance - a common measure of inflammation in traditional Chinese medicine.
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
Measured: Baseline to the end of the 1-year study follow-up period
Change in maximum urinary flow rate (Qmax) - from uroflowmetry.
Maximum urinary flow rate (Qmax) measured by uroflowmetry. Unit of Measure: Millilitres per second (mL/s)
Measured: Baseline to the end of the 1-year study follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Non-muscle Invasive Bladder Cancer (NMIBC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LifeBiotic Medical Research Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Etan Eigner, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728474
- Sponsor's protocol ID
- 0424-24-RMB
- Acronym
- LCS103
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications.
Publications
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.
PubMed 38362870Maimon 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.
PubMed 30303021Cragg 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.
PubMed 16009521Yates 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.
PubMed 15711946Antoni 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.
PubMed 27370177Matulewicz RS, Steinberg GD. Non-muscle-invasive Bladder Cancer: Overview and Contemporary Treatment Landscape of Neoadjuvant Chemoablative Therapies. Rev Urol. 2020;22(2):43-51.
PubMed 32760227Siegel 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.
PubMed 36633525
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder - Phase IIA Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07728474
- Acronym / sponsor ID
- LCS103 / 0424-24-RMB
- Keywords
- NMIBC, Bladder Cancer, Non-Muscle Invasive Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- LifeBiotic Medical Research Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| LCS103 + Standard of Care | Experimental | Dietary Supplement: LCS103Patients 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 |
| Standard of Care Alone | No intervention | –Participants in the control arm will receive SOC-recommended treatment according to risk group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCS103LCS103 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. | Dietary supplement | LCS103 + Standard of Care |
Primary outcome
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.
11 secondary outcomes
Percentage of Prescribed LCS103 Tablets Consumed, Based on Pill Count
Time frame: During the 1-year study administration period
Bladder cancer recurrence at 1 year
Time frame: During the 1-year study administration period
Bladder cancer stage or grade progression at 1 year
Time frame: Baseline to the end of the 1-year study follow-up period
Change in urinary symptom severity (IPSS)
Time frame: 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)
Time frame: Baseline to the end of the 1-year study follow-up period
Change in erectile function - male participants only (IIEF-EF)
Time frame: Baseline to the end of the 1-year study follow-up period
Change in serum C-reactive protein (CRP)
Time frame: Baseline to the end of the 1-year study follow-up period
Change in neutrophil-to-lymphocyte ratio (NLR)
Time frame: Baseline to the end of the 1-year study follow-up period
Change in urinary leucocyte count (leucocyturia)
Time frame: Baseline to the end of the 1-year study follow-up period
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 maximum urinary flow rate (Qmax) - from uroflowmetry.
Time frame: Baseline to the end of the 1-year study follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Background: PubMed 38362870Maimon 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.
- Background: PubMed 30303021Maimon 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.
- Background: PubMed 16009521Cragg 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.
- Background: PubMed 15711946Yates 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.
- Background: PubMed 27370177Antoni 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.
- Background: PubMed 32760227Matulewicz RS, Steinberg GD. Non-muscle-invasive Bladder Cancer: Overview and Contemporary Treatment Landscape of Neoadjuvant Chemoablative Therapies. Rev Urol. 2020;22(2):43-51.
- Background: PubMed 36633525Siegel 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.
- NCI SEER, Cancer Stat Facts: Bladder CancerLink provided by the sponsor.
- American Cancer Society, Intravesical Therapy for Bladder CancerLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Etan Eigner, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LCS103 in people with Non-muscle Invasive Bladder Cancer (NMIBC), run by LifeBiotic Medical Research Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yair Maimon, Dr. (+972-3-5043030, yair@tcm.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LCS103 Safety: Incidence and Severity of Treatment-Emergent Adverse Events, Graded by CTCAE v5.0 (time frame: During the 1-year LCS103 administration period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07728474, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.