March 2023

UROLOGY

CLINICAL TRIALS AT NORTHWESTERN MEDICINE UROLOGY


​New scientific discoveries that make it to the clinical trial stage offer hope for bringing new treatments closer to the patients who need them. Northwestern Medicine Urology offers clinical trials for a myriad of urologic conditions. Through just the Polsky Urologic Cancer Institute of Robert H. Lurie Cancer Center at Northwestern Medicine, we made 25 clinical studies available to patients with bladder, kidney and prostate cancers in 2022. Additionally, we enrolled more than 600 participants in clinical studies for urologic cancers and conditions.
 
The sheer scope of the clinical trials conducted at Northwestern Medicine Urology is a testament to our national reputation as the No. 12 urology program in the country, per U.S. News & World Report, 2022 – 2023. We provide the robust necessary infrastructure — clinical research staff, principal investigators and facilities — for clinical studies to be safely and successfully conducted. Industry, government and academic collaborators look to us to help them evaluate promising new urologic therapies and cures that could become the next gold standard of care.
 
Here are just a few of our ongoing clinical trials offerings:
 
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer (TAR-210) 

Northwestern Medicine Urology’s Joshua J. Meeks, MD, PhD, is collaborating with Janssen Pharmaceuticals on a phase 1 study to determine the risks and benefits of a new medication delivery system for bladder cancer. Based on the type of bladder cancer and previous treatments, patients will be placed into one of four groups. All patients will receive an investigational drug delivery system called TAR-210. Placed in the bladder, TAR-210 is a pretzel-shaped tube made from soft plastic that’s about the size of a quarter.
 
Our physicians will place TAR-210 into the bladder, where the device will release a controlled amount of the study medication directly into the bladder. This study will allow physicians and scientists to determine if there is a safe dose that can be used in other bladder cancer studies, evaluate the drug delivery system and determine how the body responds to the medication. 
 
Utilization of rhPSMA PET to Detect Occult Clinically Significant Prostate Cancer among Active Surveillance Candidates ​
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Investigators at Polsky Urologic Cancer Institute are investigating new ways to more accurately diagnose prostate cancer. Among a new class of diagnostic agents, the prostate-specific membrane antigen (PSMA) offers hope for better detecting prostate cancer. Northwestern Medicine Clinician-Scientist Ashley E. Ross, MD, PhD, has partnered with Blue Earth Diagnostics to use their radioactive imaging agent rhPSMA-7.3 [F-18]. This agent binds to prostate cancer cells to help find prostate cancer cells. Patients will be given the rhPSMA-7.3 [F-18] radioactive tracer and then will undergo a PET/MR scan to determine if the radioactive tracer will detect and identify the severity of the prostate cancer.

After the scan, all study participants will undergo a prostate biopsy or a radical prostatectomy. The PET/MR imaging along with the surgical specimens will be analyzed to determine if the radioactive tracer detects the prostate cancer and stage of disease with accuracy. PSMA PET/MR imaging is a relatively new technology and has shown improvements in initial detection and classification of prostate cancer for better guiding treatment to optimize patient outcomes.​

Evaluating Novel Approaches to Prostate Biopsy and Radical Prostatectomy 

Edward M. Schaeffer, MD, PhD, chair of Northwestern Medicine Urology, is collaborating with Jim Hu, MD, professor of Urology at Weill Medical College of Cornell University, on three multisite randomized clinical trials investigating novel approaches to prostate biopsy and radical prostatectomy. Dr. Schaeffer serves as co-PI on a National Cancer Institute R01-grant supported randomized clinical trial to evaluate in-office transperineal MRI-targeted prostate biopsy. Dr. Schaeffer and Dr. Hu are expanding on this research with support from a Patient-Centered Outcomes Research Institute award. Dr. Schaeffer serves as the Northwestern Medicine-site PI for this trial comparing infection rates and patient reported outcomes for transperineal and transrectal biopsies. 
 
Most recently, the NCI awarded Dr. Schaeffer and Dr. Hu a R01 grant for their proposal titled “PARTIAL: Pelvic fascia spARing radical prostatectomy TrIAL.” Dr. Schaeffer is co-PI on this randomized controlled trial to evaluate pelvic fascia sparing radical prostatectomy, a new surgical technique that may preserve fascial support structures and nerves that are severed and resected during conventional radical prostatectomy.   
 
Investigating the Link Between IBD and Prostate Cancer  

More than one million adults in the United States are estimated to suffer from inflammatory bowel disease, accounting for more than two million ambulatory and emergency room visits annually. This healthcare utilization may lead to an average increase of $5,000 to $8,000 in annual medical expenditure per patient. Reducing unnecessary medical interactions and expenditures in this patient group is key.  Individualized disease monitoring and health care screening may offer viable solutions.

The prostate-specific antigen (PSA) test is a screening test for prostate cancer. While PSA screening can reduce prostate cancer deaths, false-positive elevations are common especially in the setting of non-malignant prostate inflammation. False-positive results could lead to unnecessary biopsy and anxiety. Northwestern Medicine Urology scientists recently reported in a large retrospective case-control series that, after age 65, men with IBD who underwent prostate cancer screening at Northwestern Memorial Hospital had higher serum PSA values than non-IBD controls. In addition, men with IBD had a significantly higher risk of clinically significant prostate cancer even when controlling for differences in PSA and other relevant covariates. However, whether the elevation in PSA is related to inflammation in these men with IBD versus a true reflection of an increased risk of prostate cancer remains unclear. Additionally, the interplay of IBD status and screening PSA values is currently unknown. 
 
This study will measure PSA values in men with IBD before, during and after a flare. In addition, the effect of any PSA increase will be analyzed and correlated to the location of disease (rectal versus other). Study findings may help men with IBD by identifying pitfalls in prostate cancer screening for this population and aid in better stratifying and understanding the effect IBD has on the prostatic milieu. Optimizing how men with IBD are screened for prostate cancer could reduce future unnecessary healthcare encounters and expenditures. 
 
Evaluating a New Treatment for Male Infertility

Joining a select group of academic centers, Northwestern Medicine Urology is participating in a new multi-center, randomized placebo-controlled clinical trial looking at the efficacy and safety of using FSH to treat men with unexplained reduction of semen quality. In the study led by Joshua A. Halpern, MD, participants will be treated with a daily dose of the hormone or placebo for six months to see if the female partners of these men become pregnant within nine months after randomization.
 
Identifying Strategies to Improve Early Detection of Male Infertility

The advent of inexpensive and accurate home semen testing has enabled a potential paradigm shift in the approach to male fertility evaluation. Joshua A. Halpern, MD, is conducting a randomized clinical trial to assess the feasibility and utility of home semen testing for couples who are beginning to conceive. The study will also examine the impact of home semen testing in fertility-related quality of life among couples beginning attempts to conceive, as well as ability of home semen testing to increase the diagnosis and treatment of male infertility in these couples.
 
Intra-operative Loop Diuretics to Improve Same-day Discharge Rates After HoLEP

Loop diuretics (furosemide) have been given historically during the morcellation portion of HoLEP to promote urine production in the post-operative setting. However, the role of intra-operative furosemide is unknown. Led by Amy E. Krambeck, MD, chief of Endourology and Stone Disease, this study will assess if there is a significant difference in same day discharge rates after Holmium Laser Enucleation of the Prostate (HoLEP) with and without IV furosemide.
 
View more clinical trials underway at Northwestern Medicine >
 
Growing Our Clinical Trial Offerings

In April 2022, Northwestern Medicine Urology embarked on the creation of a new Clinical Trials Unit (CTU) to serve as a core resource for developing, organizing and implementing cutting-edge clinical studies. CTUs provide the essential structure required to successfully manage existing and open up new clinical trials to give patients even more access to the latest therapies. Building the CTU from the ground up, we have formed a team equipped with skills critical to running clinical studies, from adhering to regulatory processes to protect our research participants to collecting data critical for determining the safety and efficacy of the experimental medical treatment or intervention. This team includes research study coordinators, statistical support, and regulatory staff.
 
We have long provided our patients with the latest treatment options — and new hope — through leading-edge clinical trials. Now our new CTU will allow us to do much more. With a formal CTU in place, we can further strengthen our pharmaceutical company collaborations to increase the number and scope of clinical trials we can offer throughout the Northwestern Medicine system. Our ability to streamline regulatory processes and recruit more participants for studies will further establish Northwestern Medicine Urology as a go-to program for industry- and government-sponsored trials.

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