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Could a common drug keep bladder cancer away?

NCT ID NCT04375813

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase II trial tests whether a low-dose version of the drug rapamycin, called eRapa, can prevent bladder cancer from coming back in people who have already been treated for non-muscle invasive bladder cancer. About 166 participants will take eRapa or a placebo daily for one year. Researchers will track cancer recurrence, quality of life, and physical and mental function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
encapsulated rapamycin (eRapa)
What this could lead to
If it works, this could offer a new way to prevent bladder cancer from coming back, reducing the need for repeated surgeries or treatments.
What could go wrong
This is a mid-stage trial with 166 participants, so results may not apply to everyone. The drug may not improve recurrence rates, and side effects like immune suppression are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 166 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2021

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Pathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis, or T1) bladder cancer within 90 days prior to enrollment 2. Be able to give informed consent 3. Be age 18 or older 4. Patients must not be taking oral glucocorticoids at the time of enrollment or have active, uncontrolled infections. 5. No other prior non-bladder malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. Patients with localized prostate cancer who are being followed by an active surveillance program are also eligible. 6. Patients with T1 disease must have cross-sectional imaging of abdomen/pelvis demonstrating no evidence of nodal involvement or metastatic disease (MRI or CT scan) within 90 days prior to enrollment. 7. Patients with T1 disease must have re-resection confirming ≤ T1 disease within 90 days prior to enrollment. 8. Patients must have had all grossly visible papillary tumors removed within 90 days prior to enrollment or cystoscopy confirming no grossly visible papillary tumors within 90 days prior to enrollment. 9. Patients must not have received prior intravesical BCG. 10. Patients must not be pregnant or nursing as the use of Intravesical BCG is not recommended during pregnancy. Women/men of reproductive potential must have agreed to use an effective contraceptive method while on study drug and for 12 weeks after ending treatment. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. Examples of effective contraception are listed below: 1. Hormonal contraception 2. Double barrier method (condom with spermicidal cream, diaphragms with spermicidal cream or condoms with diaphragms) 3. Intrauterine device 4. Partner vasectomy In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. Both male and female patients will be required to disclose an effective contraception method during screening and agree to continue to use that contraception method through the end of their participation in the study. Exclusion Criteria: 1. Have muscle-invasive or higher (≥T2) bladder cancer 2. Unable to give informed consent 3. Under 18 years of age 4. Taking oral glucocorticoids at the time of enrollment. 5. Have active, uncontrolled infections 6. Presence of another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin) 7. Patients at risk of pregnancy that are unwilling or unable to take effective contraception during the study period or patients that are nursing during study period. Women/men of reproductive potential must have agreed to use an effective contraceptive method or will be considered ineligible for study participation. 8. Evidence of nodal involvement or metastatic disease within 90 days prior to enrollment. 9. History of prior intravesical BCG 10. History of prior Rapamycin treatment 11. Taking strong inhibitors (such as ketoconazole, voriconazole, itraconazole, erythromycin, telithromycin, or clarithromycin) or inducers of CYP3A4 and/or P-gp (such as rifampin or rifabutin).

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Conditions

The condition(s) this trial relates to.

non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • UT Health San Antonio

    San Antonio, Texas, 78229, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

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