Recruiting

Phase III Randomized Study of Intravesical Alpha1H as Neoadjuvant Therapy in Patients with Low- to Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Non‑Muscle Invasive Papillary Bladder Cancer, a type of bladder cancer that has not grown into the muscle layer of the bladder wall and is usually low‑grade and low‑to‑intermediate risk. Participants will receive a bladder‑instilled solution called Alpha1H, which is given directly into the bladder (intravesical) before the usual surgical removal of the tumor (a procedure known as TURBT). The purpose of the study is to determine whether this neoadjuvant (pre‑surgery) treatment can improve the length of time patients remain free from cancer‑related events.

In the trial, individuals are randomly assigned to either the Alpha1H treatment group or to receive the standard surgery alone. Those in the Alpha1H group will have the medication placed in the bladder for a short period before undergoing TURBT, after which they will be monitored through regular clinic visits and urine tests to check for safety and any signs of cancer returning or progressing. The study tracks overall health, any side effects such as urinary discomfort or blood in the urine, and quality‑of‑life measures over the follow‑up period.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization
After enrollment, you will be assigned by chance to either the alpha1h treatment group or the standard care group. this process is called randomization and ensures that the groups are comparable.
Step 2
Baseline assessments
Before any study medication is given, you will undergo a series of evaluations that may include physical examination, laboratory tests, imaging of the bladder, and collection of urine samples. these assessments establish your health status at the start of the trial.
Step 3
Start of alpha1h treatment
If you are assigned to the alpha1h arm, you will receive a solution for instillation that contains a dose of 37 mg/ml of the active substance. the medication is delivered directly into the bladder through a thin catheter, a method known as intravesical administration.
Step 4
Administration schedule
The alpha1h solution will be instilled in the clinic according to the study schedule. each instillation is performed by trained staff and the number of administrations, as well as the interval between them, are defined by the trial protocol.
Step 5
Monitoring for side effects
During the treatment period you will have regular visits to check for any adverse events such as pain during urination, increased urinary frequency, urinary retention, or blood in the urine. urine samples may be collected to assess safety.
Step 6
Standard turbt procedure
After completion of the neoadjuvant (pre‑surgery) phase, you will undergo a standard transurethral resection of bladder tumor (turbt). this procedure removes visible tumor tissue using a thin instrument inserted through the urethra.
Step 7
Post‑procedure assessments
Following turbt, tissue samples will be examined, and additional imaging or urine tests may be performed to evaluate the result of the surgery and any residual disease.
Step 8
Follow‑up visits
You will attend scheduled follow‑up appointments for up to several years. these visits include physical exams, urine tests, and questionnaires that measure quality of life. the primary goal of follow‑up is to determine event‑free survival, which means the time until any recurrence, progression, metastasis, or death.
Step 9
Study completion
The trial concludes after the final follow‑up visit. at that point all study data are collected, and you will be informed about the overall results of the research.

Who can join the trial?

6 criteria

Signed and dated informed consent – you must read a study form, understand it, and sign it with the date.
Having low- to intermediate-risk non-muscle invasive papillary bladder cancer (NMIBC) – this means a bladder tumor that is not aggressive, has not grown into the bladder muscle, and has a finger‑like (papillary) shape.
Being a male or female who is 18 years old or older – you must be an adult.
For women who could become pregnant, a negative pregnancy test is required – the test must show you are not pregnant.
Women who could become pregnant must agree to use reliable birth control during the study, and men who can father children must not donate sperm – this helps protect any future pregnancies.
Being able to keep the bladder full for two hours – you must be able to hold urine in your bladder for about two hours.

Who cannot join the trial?

14 criteria

Having a tumor that does not look like a finger‑shaped (papillary) growth when the bladder is first examined with a camera (cystoscopy).
Having a WHO performance status of 3 or 4, which means you are very limited in daily activities and need a lot of help.
Having taken any other experimental drug or product that is not yet approved, within one month before the first study visit or during the study.
Having an active HIV infection, meaning the HIV virus can be detected in your blood at the screening visit.
Having an active hepatitis B infection, shown by a positive hepatitis B surface antigen (HBsAg) test and detectable hepatitis B DNA (the virus’s genetic material) at screening.
Having an active hepatitis C infection, shown by a positive anti‑HCV antibody test and detectable hepatitis C RNA (the virus’s genetic material) at screening, unless you are already on stable antiviral treatment.
Having any other illness at the same time that could make you ineligible or prevent you from following the study rules.
Having already taken part in this same trial before.
Having a previous history of T1 stage or high‑grade disease in bladder tumors that came back.
Having a T1 stage or high‑grade non‑muscle invasive papillary bladder cancer, which means the tumor has grown into the inner layer of the bladder or looks more aggressive.
Having received intravesical BCG immunotherapy before, which is a treatment placed directly into the bladder to stimulate the immune system.
Having any other cancer diagnosis in the past 5 years, except for a common, low‑risk skin cancer called basal cell carcinoma (skin basalioma).
Having an acute urinary tract infection that needs antibiotics, which is a sudden infection of the bladder or kidneys.
Having had radiation therapy (radiotherapy) or chemotherapy that treats the whole body (systemic chemotherapy) before.

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Fakultni nemocnice Motol a Homolka
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Prague, Czechia

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Investigated drugs

alpha 1H is an investigational medicine that is placed directly into the bladder through a thin tube. It is a liquid that stays in the bladder for a short time before being drained. The drug is being tested to see if giving it before the usual bladder‑tumor removal surgery can help keep the cancer from coming back.

Standard transurethral resection of bladder tumor (TURBT) is a common surgical procedure where a doctor removes visible tumors from the inside of the bladder using a small camera and instruments. This procedure is the usual treatment for low‑ to intermediate‑risk non‑muscle‑invasive bladder cancer and serves as the control treatment in the study.

Alpha1H

What is already known about the treatment

Alpha1H - Alpha1H is supplied as a sterile solution that is placed directly into the bladder through a thin tube (intravesical instillation). It is still investigational and currently being tested in a Phase III trial, so it is not yet approved for routine use. The drug is being studied for patients with low‑ to intermediate‑risk non‑muscle invasive papillary bladder cancer, aiming to reduce tumor recurrence after surgery. It works by interfering with cellular signals that encourage cancer cells to grow, and it is classified as an investigational intravesical antineoplastic agent.

Investigated diseases

Non‑Muscle Invasive Papillary Bladder Cancer - It is a cancer that forms papillary (finger‑like) growths on the inner surface of the bladder. The tumor remains confined to the lining and does not reach the muscle layer of the bladder wall. Over time it can grow larger, reappear after removal, or gradually extend into deeper layers of the bladder.