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Clinical Trials

Clinical trials are research studies that help doctors find new and better ways to prevent and treat cancer. Almost every cancer treatment that is saving lives today is the result of a clinical trial.

The Polsky Urologic Cancer Institute offers innovative clinical research trials that provide patients with access to the most advanced treatments for bladder, kidney, prostate and testis cancers. If you have been diagnosed with a urologic cancer, feel that you are at high risk of being diagnosed with a urologic cancer or if you are a survivor, ask your doctor if a clinical trial is right for you.

Search below to find clinical trials related to urologic cancer and visit the About Clinical Trials page on the Lurie Cancer Center website to learn more about oncology clinical trials. 

Trials

The effect of inflammatory bowel disease flares on serum prostate specific antigen

This study will measure PSA values in men with IBD before, during, and following a flare. In addition, the effect of any PSA increase will be analyzed and correlated to the location of the disease (rectal vs. other). Study findings may help men with IBD by identifying pitfalls in prostate …
This study will measure PSA values in men with IBD before, during, and following a flare. In addition, the effect of any PSA increase will be analyzed and correlated to the location of the disease (rectal vs. other). Study findings may help men with IBD by identifying pitfalls in prostate cancer screening for this population and help to stratify and understand the effect IBD has on the prostatic milieu. By optimizing how men with IBD are screened for prostate cancer, future unnecessary healthcare encounters and expenditures may be reduced for this patient group.
Eligibility CriteriaMen with a confirmed diagnosis of inflammatory bowel disease (IBD) between the ages of 40-69 years old.
Principal InvestigatorKundu, Shilajit DKundu, Shilajit D
ClinicalTrials.gov IdentifierNCT03558048IRB number STU00207583
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PD-inhibitor (Nivolumab) and Ipilimumab followed by nivolumab vs. VEGF TKI cabozantinib with nivolumab in metastatic untreated REnal Cell CancEr [PDIGREE]

This study is being done to answer the following question: Can we prolong life for patients withadvanced kidney cancer, by adding a drug called cabozantinib to another treatment afterreceiving the standard treatment?We are doing this study because we want to find out if this approach isbetter or worse than …

This study is being done to answer the following question: Can we prolong life for patients with

advanced kidney cancer, by adding a drug called cabozantinib to another treatment after

receiving the standard treatment?

We are doing this study because we want to find out if this approach isbetter or worse than the usual approach for your advanced kidney cancer. The usual approach is defined as care mostpeople get for advanced kidney cancer.

Eligibility Criteria-Participants must be 18 years of age or older

-Participants must be diagnosed with advanced kidney cancer

Principal InvestigatorVanderWeele, David JamesVanderWeele, David James
Location(s)
  • Map it 201 E. Huron St.
    Chicago, IL
ClinicalTrials.gov IdentifierNCT03793166IRB number STU00210884
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Randomized controlled trial assessing transperineal prostate biopsy to reduce infection complications

Prostate cancer is the most commonly diagnosed malignancy in U.S. men. There are approximately 1 million prostate biopsy performed annually in the U.S. Almost all biopsies are performed as an office based procedure in under 15 minutes. The precision of biopsy has improved over the last decade with …

Prostate cancer is the most commonly diagnosed malignancy in U.S. men. There are approximately 1 million prostate biopsy performed annually in the U.S. Almost all biopsies are performed as an office based procedure in under 15 minutes. The precision of biopsy has improved over the last decade with the introduction of MRI guidance/targeting of suspicious lesions within the prostate.

However, significant limitations remain with this approach, including a significantly increasing risk of post-biopsy infection. This arises because more than 97% of all prostate biopsy are performed via a transrectal approach that introduces rectal bacteria with each pass of the biopsy needle into the sterile urinary tract. The current risk of post-transrectal biopsy infection, even with antimicrobial prophylaxis, is high at approximately 7% overall with 3% (30,000 men) requiring hospitalization annually.

Transperineal biopsy is an alternate approach that eliminates the direct introduction of bacteria from the rectum to the prostate. This approach, which is perfomed without antimicrobial prophylaxis, instead passes the biopsy needle through the perineal skin and pelvic floor.

Transperineal biopsy has not been widely adopted for several reasons. Historically, it has been considered too painful for patients in the clinic and thus was traditionally performed under general anesthesia. The added time, inconvenience and cost has limited its national adoptance. Second, when transrectal biopsy was initially adopted over 40 years ago, antibiotic resistance of rectal flora was not a challenge.

Beyond the potential for in-office transperineal biopsy to significantly reduce or eliminate biopsy infections, transperineal biopsy may also improve cancer detection: studies of transperineal biopsy (performed under general anesthesia) demonstrate higher detection rates for prostate cancer, particularly for anterior zone tumors, compared to transrectal biopsy. This is notable, as anterior tumors are difficult to sample with transrectal. Anterior tumors are also twice as likely to occur in African American men. In fact, our research demonstrates that some of the outcomes disparities in African American men may stem from an underdiagnosis of anterior prostate cancers.

Although transrectal biopsy is used widely, it is associated with a significant and increasing risk of biopsy infections due to growing antibiotic resistance, highlighting the urgent need for a safer alternative approach to prostate biopsy. The study investigators have refined a transperineal approach under local anesthesia with MRI-targeting/guidance without the need for antibiotic prophylaxis. The investigators hypothesize that transperineal MRI targeted biopsy will: (1) largely eliminate post-biopsy infections and costly hospitalizations for urosepsis; (2) be performed in the office with similar discomfort and non-infectious complications compared to transrectal MRI targeted biopsy; and (3) have significantly better detection of prostate cancer.

This multi-center randomized controlled trial will be conducted to evaluate in-office transperineal MRI targeted vs. transrectal MRI targeted biopsy, the current gold standard. This has transformative impact to change current standard of practice.

Eligibility CriteriaThis study will include allmen who are recommended to undergo prostate biopsy as part of routine clinicalcare.
Principal InvestigatorSchaeffer, Edward MatthewSchaeffer, Edward Matthew
ClinicalTrials.gov IdentifierNCT04815876IRB number STU00211699
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