Actively Recruiting
Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention
Led by Robert Svatek · Updated on 2025-05-15
166
Participants Needed
2
Research Sites
257 weeks
Total Duration
On this page
Sponsors
R
Robert Svatek
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed diagnosis of non-muscle invasive (Ta, Tis, or T1) bladder cancer within 90 days before enrollment
- Able to provide informed consent
- Age 18 years or older
- Not taking oral glucocorticoids at registration
- No active, uncontrolled infections
- No other active cancers except treated basal or squamous cell skin cancer, in situ cervical cancer, treated Stage I or II cancers in remission, or cancers disease-free for 5 years
- Patients with localized prostate cancer under active surveillance are eligible
- Not pregnant or nursing; men and women of reproductive potential must agree to use effective contraception
- All visible papillary tumors removed or cystoscopy confirming no visible tumors within 90 days before registration
- For T1 disease, imaging showing no nodal or metastatic disease within 90 days before registration and re-resection confirming T1 disease within 90 days
- No prior intravesical BCG treatment
You will not qualify if you...
- Muscle-invasive or higher (≥T2) bladder cancer
- Unable to provide informed consent
- Age 17 years or younger
- Taking oral glucocorticoids at registration
- Another cancer needing active treatment (except basal or squamous cell skin cancer)
- At risk of pregnancy but unwilling or unable to use effective contraception during study or nursing
- Imaging showing nodal involvement or metastatic disease within 90 days before registration
- History of prior intravesical BCG treatment
- History of prior rapamycin treatment
AI-Screening
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Trial Site Locations
Total: 2 locations
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
2
UT Health San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
F
Fred Norton, BS
CONTACT
R
Robert S Svatek, MD, MSC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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