Join a Bladder Cancer Clinical Trial to Help Reduce the Risk of Recurrence!

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Cancer survivors face the possibility that cancer will come back after treatment.

Clinical trials are studies that help researchers learn more to help slow, manage, and treat cancer, as well as prevent cancer recurrence.

If you have had bladder cancer, you can volunteer for a bladder cancer prevention clinical trial that is studying encapsulated rapamycin (eRapa) and its ability to reduce the risk of bladder cancer recurrence.

This trial is led by researchers across Texas, including UT Health San Antonio, UT Southwestern Medical Center, and South Texas Veterans Health Care System, to explore new ways to prevent bladder cancer from coming back.

“Unfortunately, people who’ve had bladder cancer have a high risk of developing a second bladder cancer,” said Dr. Amelie Ramirez, director of the Institute for Health Promotion Research and the Salud America! program at UT Health San Antonio, citing the American Cancer Society. “Researchers rely on volunteers in clinical trials to help identify the best treatments to prevent bladder cancer recurrence. Volunteering could help future cancer survivors in your family, community, and city.”

Join the eRapa Bladder Cancer Prevention Clinical Trial at UT Health San Antonio by contacting Fred Norton, BS, at 210-450-9630 or nortonk1@uthscsa.edu

What is the eRapa Bladder Cancer Prevention Clinical Trial?

Researchers, led by Dr. Robert Svatek of UT Health San Antonio, are evaluating the effectiveness of eRapa in preventing bladder cancer recurrence.

They are seeking people with non-muscle invasive bladder cancer to volunteer for a double-blind clinical trial, which gives some participants the drug itself while others will receive a placebo.

“Comparing results from the two groups suggests whether changes in the test group result from the treatment or occur by chance,” according to the National Institute of Health. “In many trials, no one—not even the research team—knows who gets the treatment, the placebo, or another intervention. When participants, family members, and staff all are ‘blind’ to the treatment while the study is underway, the study is called a ‘double-blind, placebo-controlled’ clinical trial.”

Researchers will study: Comment Now: Tell HHS How to Improve Healthcare for Latinos!

  • Change in Cognitive Function
  • Determine 1-year Recurrence Free Survival (RFS) rate
  • Change in Urinary Quality of Life
  • Change in cytoscopy consistent with recurrence
  • Change in Short Physical Performance Battery
  • Change in Handgrip Strength

“The primary hypothesis is that eRapa decreases the risk of cancer relapse for patients with [non-muscle invasive bladder cancer] NMIBC,” according to the clinical trial webpage. “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.” 

Join the eRapa Bladder Cancer Prevention Clinical Trial at UT Health San Antonio by contacting Fred Norton, BS, at 210-450-9630 or nortonk1@uthscsa.edu

Who Can Volunteer for the eRapa Bladder Cancer Prevention Clinical Trial?

The study is seeking people with a pathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis, or T1) bladder cancer within 90 days prior to enrollment.

Inclusion criteria include:

  • Pathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis, or T1) bladder cancer within 90 days prior to enrollment
  • Able to give informed consent
  • 18 years or older
  • Patients must not be taking oral glucocorticoids at the time of registration
  • Not 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 survelillance program are also eligible.
  • 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.
  • Patients must have had all grossly visible papillary tumors removed within 90 days prior to registration or cystoscopy confirming no grossly visible papillary tumors within 90 days prior to registration.
  • 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 registration. Patients with T1 disease must have re-resection confirming ≤ T1 disease within 90 days prior to registration.
  • Patients must no have received prior intravesical BCG

Exclusion criteria include:

  • Have muscle-invasive or higher (≥T2) bladder cancer
  • Unable to give informed consent
  • Age 17 or younger
  • Taking oral glucocorticoids at the time of registration
  • 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 the 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 (MRI or CT scan) within 90 days prior to registration
  • History of prior intravesical BCG
  • History of prior Rapamycin treatment

Join the eRapa Bladder Cancer Prevention Clinical Trial at UT Health San Antonio by contacting Fred Norton, BS, at 210-450-9630 or nortonk1@uthscsa.edu

What Will Volunteers Do as Part of the eRapa Bladder Cancer Prevention Clinical Trial?

Researchers will conduct this study in the following ways:

  • Subjects will receive low dose (0.5 mg) eRapa Monday through Friday for one year or until a recurrence of bladder cancer.
  • Patients will also undergo endoscopic evaluation of the bladder every 3 months for 2 years, and then every 6 months for 2 years.
  • Patient-reported outcome assessments, cognitive assessments, and physical assessments will also be completed according to the study calendar. stomach cancer abdominal pain gastric cancer latino latina
  • Research blood to assess safety, immune response and rapamycin level will be collected regularly throughout the study period.
  • Participants will be followed for up to 5 years following enrollment.

Join the eRapa Bladder Cancer Prevention Clinical Trial at UT Health San Antonio by contacting Fred Norton, BS, at 210-450-9630 or nortonk1@uthscsa.edu

Contact Now to Volunteer for the the eRapa Bladder Cancer Prevention Clinical Trial!

People with bladder cancers know firsthand why trials like these can make a big difference as the treatments they receive today were once under consideration through clinical trials.

“If more people could step up to volunteer for studies such as these, headway could be made in saving the lives of countless people and their family members,” Ramirez said.

Even if this cancer doesn’t run in your family, you can volunteer for another clinical trial.

We need Latino volunteers for clinical trials because it helps researchers create treatments and solutions tailored for this population.

Just ask Alma Lopez.

Breast cancer is the top cause of death for Latinas, but Alma Lopez has been a breast cancer survivor for more than 15 years.

She believes participating in a clinical trial at UT Health San Antonio helped her get better treatment and better long-term health.

“Clinical trials are great for finding new treatments that help people,” Lopez said. “And it helps the scientists. It gives opportunity to better medication for all populations.”

FIND A CLINICAL TRIAL!

 Join the eRapa Bladder Cancer Prevention Clinical Trial at UT Health San Antonio by contacting Fred Norton, BS, at 210-450-9630 or nortonk1@uthscsa.edu

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