Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Non-muscle Invasive Bladder Cancer

In brief

eRapa (encapsulated rapamycin) will be investigated for secondary prevention in patients with diagnosed non-muscle invasive bladder cancer (NMIBC) through a phase II double-blind randomized controlled trial of long-term (one year) prevention with eRapa versus placebo. The primary hypothesis is that eRapa decreases the risk of cancer relapse for patients with NMIBC. Secondary hypotheses are that eRapa can improve certain immune parameters and improve cognition and physical function without adversely affecting patient-reported outcomes and quality of life.

Key facts

Study ID

NCT04375813

Run by

Robert Svatek

People needed

166

Starts

2021-01-25

Expected to finish

2027-07-01

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis, or T1) bladder cancer within 90 days prior to enrollment
• Be able to give informed consent
• Be age 18 or older
• Patients must not be taking oral glucocorticoids at the time of enrollment or have active, uncontrolled infections.
• 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.
• 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.
• Patients with T1 disease must have re-resection confirming ≤ T1 disease within 90 days prior to enrollment.
• 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.
• Patients must not have received prior intravesical BCG.
• 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:
• Hormonal contraception
• Double barrier method (condom with spermicidal cream, diaphragms with spermicidal cream or condoms with diaphragms)
• Intrauterine device
• 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.

You may not qualify if…

• Have muscle-invasive or higher (≥T2) bladder cancer
• Unable to give informed consent
• Under 18 years of age
• Taking oral glucocorticoids at the time of enrollment.
• Have active, uncontrolled infections
• Presence of another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin)
• 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.
• Evidence of nodal involvement or metastatic disease within 90 days prior to enrollment.
• History of prior intravesical BCG
• History of prior Rapamycin treatment
• 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).

Where it is running

• UT Southwestern Medical Center — Dallas, Texas, United States
• UT Health San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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