Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention (NCT04375813)

🧪 Interventions in This Study

• eRapa (DRUG)
• Placebos (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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:
11. Hormonal contraception
12. Double barrier method (condom with spermicidal cream, diaphragms with spermicidal cream or condoms with diaphragms)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

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

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Non-muscle Invasive Bladder Cancer

• A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer — Tampa, Florida
• A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer — Birmingham, Alabama
• Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment — Basking Ridge, New Jersey
• A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer — Birmingham, Alabama
• Sample Collection for Ongoing Research and Product Evaluation Study - Non-muscle Invasive Bladder Cancer (SCORE-NMIBC) — Austin, Texas
• A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027) — Bakersfield, California

Explore by condition: All Non-muscle Invasive Bladder Cancer clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.