A Multi-Phase Study of Active Surveillance for Men with Clinical Stage T1c or T2a Localized Prostate Cancer
Aims: NorthShore has the largest institutionally reviewed* and approved Prostate Cancer Active Surveillance program in the region.
Active Surveillance in prostate cancer refers to an increasingly accepted strategy for following men with relatively low-risk, early-stage prostate cancer. Active Surveillance offers men an alternative to surgery and radiation, and may spare them possible side effects of traditional therapy including urinary incontinence, rectal bleeding and sexual dysfunction, allowing them to maintain their current quality of life.
These men are monitored carefully with ongoing examinations, blood and urine tests, and periodic biopsies with MRI to monitor cancer progression. Extra blood and tissue samples are obtained for research purposes, and information on quality of life, including anxiety and sexual health, is also collected.
Most men who enroll in Active Surveillance will never require treatment, but if at any point a participant’s cancer has significantly progressed, patients will be advised to undergo treatment and will be provided comprehensive information on treatment options to cure their cancer. Our protocol allows those men who eventually need treatment to be managed promptly and effectively without compromising treatment outcomes.
The goal of our clinical trial is to develop better biological tests that will help identify and distinguish those men who should be treated soon after diagnosis from those who can be safely followed without treatment for many years.
Diagnosis: Early stage prostate cancer and have chosen a program of active surveillance rather than active treatment.
Principal Investigator: Dr. Kristian Novakovic, MD
IRB Approval Number: EH09-043
Sponsor: NorthShore University HealthSystem
Contact: Study Coordinator, Svetlana Brumer at 847.503.3087
Open to Enrollment: Yes
The Establishment of a Comprehensive Urologic Disease Biorepository and Database
Aims: The overall goal of this study is the collection of high-quality biologic samples from patients with a wide range of urologic diseases, along with collection of corresponding clinical data. There is a great need to validate (confirm the worth of) biomarker and genetics (DNA) studies among real patients with urologic diseases. By creating a large database of information from urology patients, we will be able to expand the current knowledge of how to best detect and treat urologic diseases. These findings could lead to other clinical trials, or even uncover previously undiscovered biomarkers and genetic components of urologic diseases.
Diagnosis: Diagnosed or suspected urologic disease
Principal Investigator: Dr. Kathy Mangold, PhD
IRB Approval Number: EH15-091
Sponsor: NorthShore University HealthSystem
Contact: Study Coordinator, Svetlana Brumer at 847.503.3087
Open to Enrollment: Yes
There have been several important scientific publications resulting from data collected from these studies. To view the list of publications, click here
Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry
Aims: The purpose of this study is to understand and collect real world safety and performance data for BSC ureteral and urinary diversion stents. The study is an observation of your medical condition for a period of time after the initial implant of the device, which means that the underlying procedure by which the device is implanted is not considered part of the study. Implant of Ureteral stents is considered the standard for the treatment of obstructed ureters or those with the potential to obstruct. Ureteral Stents are approved for commercial use in the United States. Your doctor’s use of the device to treat your medical condition is the standard of care at NorthShore University HealthSystem.
Diagnosis: Medical condition requires a temporary ureteral stent
Principal Investigator: Dr. Alexander Glaser, MD
IRB Approval Number: EH21-313
Sponsor: Boston Scientific
Contact: Study Coordinator, Svetlana Brumer at 847.503.3087
ClinicalTrials.gov Identifier: NCT04197583
Open to Enrollment: No
Enhanced Clinical Decisions for Management of Benign Prostatic Hyperplasia Using Patient-Reported Outcomes
Aims: Use new, updated questionnaires and clinical assessments to enhance clinical decision-making in men with benign prostatic hyperplasia (enlarged prostate)
Diagnosis: Benign prostatic hyperplasia (BPH)
Principal Investigator: Dr. Alexander Glaser, MD
IRB Approval Number: EH22-021
Sponsors: National Institutes of Health
Contact: Research Coordinator, Dacey Maglaque at 847.503.4278
Open to Enrollment: Yes
Observational and Prospective Study on the Performance of Inherited Risk Assessment for Predicting Prostate Cancer from Prostate Biopsy
Aims: The purpose of this research is to study how genetic testing can be used to improve the practices we use to screen for prostate cancer. This may help identify patients who inherited a higher risk for developing prostate cancer who would benefit by undergoing prostate biopsies. This may also help reduce the number of unnecessary biopsies for other patients who inherited a lower risk for developing prostate cancer.
Diagnosis: Undergoing a prostate biopsy (a procedure for taking a small sample of prostate tissue) for the purpose of detecting prostate cancer as part of your clinical care
Principal Investigator: Dr. Jianfeng Xu, MD, DrPH
IRB Approval Number: EH21-338
Sponsor: NorthShore University HealthSystem
Contact: Research Study Coordinator, Margaret Antoniak at 847.503.4282
ClinicalTrials.gov Identifier: NCT05295407
Open to Enrollment: Yes
Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Urinary Urgency
Aims: The purpose of this study is to improve our understanding of lower urinary tract symptoms (LUTS) and to learn more about people’s experiences, along with how to measure different aspects of the people’s LUTS experiences.
Diagnosis: Lower urinary tract symptoms (LUTS)
Principal Investigators: Dr. Brian Helfand, MD, PhD and Dr. Alexander Glaser, MD
IRB Approval Number: EH20-411
Sponsor: The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact: Research Study Coordinator, Margaret Antoniak at 847.503.4282
ClinicalTrials.gov Identifier: NCT04557748
Open to Enrollment: Yes
A Randomized Phase 3, Open-Label Trial of Sipuleucel-T Administered to Patients on Active Surveillance for Newly Diagnosed Prostate Cancer
Aims: To learn more about a prostate cancer treatment called sipuleucel-T, a cell-based immunotherapy, in early stage prostate cancer that has not spread outside of the prostate. Sipuleucel-T has been approved by the FDA for treatment of metastatic castrate resistant prostate cancer. Use of sipuleucel-T for the treatment of other types of cancer, including prostate cancer that is not metastatic, is investigational. Patients will be asked to comply with study protocols.
Diagnosis: Men with prostate cancer that is lower risk and has not spread outside of the prostate within the previous 12 months.
Principal Investigator: Dr. Kristian Novakovic, MD
Sponsor: Dendreon Pharmaceuticals LLC
Contact: Research Manager, Pooja Talaty at 847.503.4280
ClinicalTrials.gov Identifier: NCT03686683
Open to Enrollment: No
A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men with Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)
Aims: The purpose of this study is to find out if vibegron is effective, safe, and tolerated in men with OAB symptoms while taking medication for BPH.
Diagnosis: 45 years of age or older with a body weight of 50 kg (approximately 110 lbs) or more. You must be experiencing OAB symptoms while taking medication to treat lower urinary tract symptoms due to BPH.
Principal Investigator: Dr. Alexander Glaser, MD
Sponsor: Urovant Sciences, GmbH
Contact: Research Coordinator, George Javitch at 847.503.4281
ClinicalTrials.gov Identifier: NCT03902080
Open to Enrollment: No
Safety and Effectiveness Study of the Zenflow Spring System - A Minimally Invasive Treatment for LUTS associated with BPH (BREEZE Study)
Aims: The purpose of this research is to evaluate the safety and effectiveness of the Zenflow Spring System in relieving symptoms of obstructive Benign Prostatic Hyperplasia (BPH), which affects your urinary outflow. Results of this study will be used to apply for US Food and Drug approval/clearance (commercial licensing) of the Zenflow Spring System to treat patients with BPH.
Diagnosis: Confirmed diagnosis of BPH.
Principal Investigator: Dr. Brian Helfand, MD, PhD and Dr. Alexander Glaser, MD
Sponsor: Zenflow, Inc.
IRB Approval Number: EH22-378
Contact: Pooja Talaty at 847.503.4280 or Margaret Antoniak at 847.503.4282
ClinicalTrials.gov Identifier: NCT04987138
Open to Enrollment: No
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Pivotal Study of the NanoKnife System for Ablation of Prostate Tissue in an Intermediate Risk Patient Population
Aims: This study is being run for research purposes. The study device, NanoKnife® System, is being tested for the treatment of early-stage prostate cancer. The purpose of this study is to learn more about the use of the NanoKnife System for the treatment of early-stage prostate cancer. The NanoKnife is a type of irreversible electroporation (IRE) device. “Electroporation” is a cellular destruction technology that can be used to treat cancer. It uses electrical pulses to make small holes in cells that result in cell death .
Diagnosis: Prostate cancer and you are a candidate for electroporation treatment .
Principal Investigator: Dr. Brian Helfand and Dr. Alexander Glaser
Sponsor: AngioDynamics
IRB Approval Number: EH22-009
Contact: Svetlana Brumer at 847.503.3087
ClinicalTrials.gov Identifier: NCT04972097
Open to Enrollment: Yes