{"id":4717,"date":"2019-01-15T15:58:03","date_gmt":"2019-01-15T20:58:03","guid":{"rendered":"https:\/\/www.med.unc.edu\/urology\/?page_id=4717"},"modified":"2022-09-19T15:48:31","modified_gmt":"2022-09-19T19:48:31","slug":"clinical-trials","status":"publish","type":"page","link":"https:\/\/www.med.unc.edu\/urology\/research\/clinical-trials\/","title":{"rendered":"Clinical Trials"},"content":{"rendered":"

Innovations in healthcare are made possible through clinical trials. Clinical trials are research studies involving human participants that evaluate the effects of new tests, drugs, interventions, or procedures on health outcomes. Participation in clinical trials may enable you to take a more active role in your own health care, gain access to new tests and treatments before they are widely available, and help others by contributing to medical research.<\/p>\n[expand title=”Read More”]\nHuman studies, or clinical trials, are sponsored or funded by a variety of sources such as physicians, hospitals, foundations, pharmaceutical companies, voluntary or advocacy groups, universities and government agencies. Ideas for clinical trials usually come from researchers. These researchers will test new therapies or procedures in the laboratory and in animal studies, and the most promising results move on to clinical trials.<\/p>\n

Choosing to participate in a clinical trial is an important personal decision. Carefully conducted clinical trials are the fastest and safest way to find whether new drugs or treatments are both safe and effective. Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. All clinical trials have guidelines about who can participate. Researchers have protocols with defined criteria to identify appropriate participants and maintain safety standards.<\/p>\n

In addition to the trials developed at UNC, there are national trials that you can learn about by visiting the National Institutes of Health website at clinicaltrials.gov<\/a>.
\n[\/expand]\n

\"\"<\/a><\/p>\n

Research for Me is dedicated to connecting you with research opportunities at UNC-Chapel Hill, UNC Health, and across North Carolina.<\/p>\n

Find Studies<\/a><\/p>\n

 <\/p>\n

UNC Urology Clinical Trials<\/h2>\n
\n
(Quilt 2.005) A study of intravesical Bacillus Calmette-Guerin (BCG) in Combination with ALT-803 in Patients with Non-Muscle Invasive Bladder Cancer<\/h5>\n
\n
\nPrincipal Investigator<\/u>: Marc Bjurlin, DO, MSc, FACOS<\/a>
\nSponsor<\/u>: Immunity Bio<\/a>
\nContact<\/u>: Shannon Myers (ph: 919-843-1130<\/a>)<\/p>\n

This study tests the safety and efficacy of intravesical BCG plus ALT-803 in patients with high grade non-muscle invasive bladder cancer that have never had BCG treatments before.<\/p>\n

https:\/\/clinicaltrials.gov<\/a><\/div>\n

\n\"Marc<\/a>\n<\/div>\n<\/div>\n
\n
Prospective Validation of Prostate Biomarkers for Repeat Biopsy: The PRIORITY Study<\/h5>\n
\n
\nPrincipal Investigator<\/u>: Marc Bjurlin, DO, MSc, FACOS<\/a>
\nSponsor<\/u>: MDxHealth<\/a>
\nContact<\/u>: Shannon Myers (ph: 919-843-1130<\/a>)<\/p>\n

This study tests the validity of two prostate cancer screening tests to help guide physicians\u2019 decisions about patient care and reduce the need for multiple prostate biopsies.<\/p>\n

Eligible patients will have previously had a negative prostate biopsy and are planning a repeat biopsy.<\/i><\/p>\n

https:\/\/clinicaltrials.gov\/<\/a><\/div>\n

\n\"Marc<\/a>\n<\/div>\n<\/div>\n
\n
QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination with ALT-803 in Patients with BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer<\/h5>\n
\n
\nPrincipal Investigator<\/u>: Marc Bjurlin, DO, MSc, FACOS<\/a>
\nSponsor<\/u>: Immunity Bio<\/a>
\nContact<\/u>: Shannon Myers (ph: 919-843-1130<\/a>)<\/p>\n

This study tests the safety and efficacy of intravesical BCG plus ALT-803 in patients with high grade non-muscle invasive bladder cancer that have previously failed BCG.<\/p>\n

More information<\/u>: https:\/\/clinicaltrials.gov\/<\/a><\/div>\n

\n\"Marc<\/a>\n<\/div>\n<\/div>\n
\n
GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses<\/h5>\n
\n
\nPrincipal Investigator<\/u>: Hung-Jui Tan, MD, MSHPM<\/a>
\nSponsor<\/u>: Lineberger Comprehensive Cancer Center UCRF<\/a>
\nContact<\/u>: Shannon Myers (ph: 919-962-8838<\/a>)<\/p>\n

This is a non-randomized, comparative study to evaluate the role of renal mass biopsy on decision-making for patients presenting with clinical T1 kidney tumors. This trial will also determine if genomic information can be accurately obtained from renal mass biopsy samples to help guide management decisions.<\/p>\n

https:\/\/clinicaltrials.gov<\/a><\/div>\n

\n<\/a>\n<\/div>\n<\/div>\n
\n
A Study of Apalutamide in Participants With High\u2011Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy (PROTEUS)<\/h5>\n
\n
\nPrincipal Investigator<\/u>: Marc Bjurlin, DO, MSc, FACOS<\/a>
\nSponsor<\/u>: Janssen Research & Development, LLC<\/a>
\nContact<\/u>: Shannon Myers (ph: 919-843-1130<\/a>)<\/p>\n

This is a randomized trial comparing androgen deprivation therapy (ADT) plus apalutamide vs ADT and placebo. Treatment is given before and after radical prostatectomy in participants with high-risk localized or locally advanced prostate cancer.<\/p>\n

https:\/\/clinicaltrials.gov<\/a><\/div>\n

\n\"Marc<\/a>\n<\/div>\n<\/div>\n
\n
Comparing Intravesical Therapy & Surgery as Treatment Options (CISTO)<\/h5>\n
\n
\nPrincipal Investigator<\/u>: Angela Smith, MD, MS, FACS<\/a>
\nSponsor<\/u>: PCORI<\/a>
\nContact<\/u>: Dana Mueller (ph: 919-962-4671<\/a>)<\/p>\n

CISTO is a pragmatic observational study to compare patient-reported and patient-centered clinical outcomes between patients undergoing radical cystectomy and those receiving bladder-sparing intravesical therapies for NMIBC that have failed first-line BCG.<\/p>\n

cistostudy.org<\/a><\/div>\n

\n<\/a>\n<\/div>\n<\/div>\n
\n
(EA8184) A Phase II Randomized Double Blinded Study of Green Tea Catechins (GTC) vs. Placebo in Men on Active Surveillance for Prostate Cancer: Modulation of Biological and Clinical Intermediate Biomarkers<\/h5>\n
\n
\nPrincipal Investigator<\/u>: Marc Bjurlin, DO, MSc, FACOS<\/a>
\nSponsor<\/u>: ECOG-ACRIN<\/a>
\nContact<\/u>: Shannon Myers (ph: 919-843-1130<\/a>)<\/p>\n

Can we lower the chance of your prostate cancer growing by adding Sunphenon\u00ae 90D (containing green tea catechins) by closely monitoring your prostate cancer?<\/p>\n

https:\/\/clinicaltrials.gov<\/a><\/div>\n

\n\"Marc<\/a>\n<\/div>\n<\/div>\n
\n
(S1600) Randomized Phase III Double-Blind Clinical Trial Evaluating The Effect Of Immune-Enhancing Nutrition On Radical Cystectomy Outcomes (SIMmune)<\/h5>\n
\n
\nPrincipal Investigator<\/u>: Marc Bjurlin, DO, MSc, FACOS<\/a>
\nSponsor<\/u>: SWOG<\/a>
\nContact<\/u>: Shannon Myers (ph: 919-843-1130<\/a>)<\/p>\n

The purpose of this study is to test whether improving nutrition before and after surgery can reduce the infections and other problems that sometimes occur after surgery.<\/p>\n<\/div>\n

\n\"Marc<\/a>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

[expand title=”Read More”] Human studies, or clinical trials, are sponsored or funded by a variety of sources such as physicians, hospitals, foundations, pharmaceutical companies, voluntary or advocacy groups, universities and government agencies. Ideas for clinical trials usually come from researchers. 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