Clinical research and trial development is a broad iniative and strength of the Division of Urology at BWH. In the urology clinic, the surgeons divide their time between patient care, medical education and research. Our division is currently engaged in a variety of studies that further our research endevours, provide solid academic traction, address previously unmet research niches and, most importantly, provide alternative therapies for current patients. As a nationally known leader in investigating and treating various urological diseases, the Division of Urology is committed to investigating the underlying causes of diseases, as well as developing preventative treatment measures.
While there are a variety of traditional treatment options, our surgeons also explore alternative, investigational treatments, through the wide range of clinical trial options. These investigations include:
- Laboratory studies using genomic and biochemical approaches to investigate molecular mechanisms of prostate cancer development and progression (The Jia Lab)
- Patient-reported outcomes studies evaluating short-term surgical results and their ability to translate into long-term care. Utilizing questionnaires and surveys administered in clinic allow surgeons a better understanding of long-term results of different treatment options
- Clinical trials assessing existing, alternative and investigational therapies
The clinical research team manages upwards of 12 trials, both cancer and non-cancer. Each trial has a complex protocol and inclusion criteria for patients. The availability of clinical trials allows the providers to explore a range of alternative therapies for almost each disease and patient population indication the division supports.
Examples of our current studies include:
- A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Subjects with High-Risk NMIBC unresponsive to BCG Therapy (Funded by Merck): Dr. Mark Preston leads this trial exploring an alternative drug therapy for patients with non-muscle invasive bladder cancer.
- Prospective Validation of Prostate Biomarkers for Repeat Biopsy: The PRIORITY Study (Funded by MDXHealth, Inc.): Dr. Adam Kibel leads this study evaluating patients with prostate cancer by utilizing a sponsor developed test. The goal is to help physicians identify patients with an increased risk for prostate cancer and lower the rate of repeat biopsies.
- Underactive Bladder: Epidemiologic Analyses, Screener Development and Validation (Funded by NIDDK): Dr. Michael O’Leary oversees this trial focusing on the developing and validating instruments for early identification of individuals potentially at risk for detrusor underactivity by increasing clinician and individual awareness of underactive bladder symptoms and lowering the threshold for activation for early intervention.
- Patient-Centered Surgical Prehabilitation: Matthew Mossanen has developed a program aimed at improving patient preparation for cystectomies, a complex operation subject to complications and readmissions. There is potential value to improve outcomes by offering patients the ability to engage in healthy lifestyle behaviors geared at promoting better physical functioning, psychological well-being, and mental resiliency.
- Evaluation of pain before and after removal of non-obstructing renal calculi: The pNORC Study: Daniel Wollin spearheads this study evaluating pain levels after removal of kidney stones.
- Pilot study of an implantable microdevice to test multiple drug responses in prostate cancer patients (Funded by NIH-NCI): Dr. Adam Kibel, in conjunction with Investigators from the Department of Radiology are piloting a study to assess the feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in locally advanced prostate cancer.
- The role of PARP2 in prostate cancer (Funded by US Army Medical Research Acquisition Activity): Li Jia examines selective targeting of PARP2 and if it inhibits prostate cancer growth and progression in specific pre-clinical settings. This study is interested in elucidating the distinct roles of PARP1 and PARP2 in AR signaling and prostate cancer growth, and the benefits of selective PARP inhibition under different clinical settings.
- Evaluating the Fiscal and Readiness Impacts of Consolidating Care of Complex Patients in the Capitol Region (Funded by Uniformed Services University of the Health Services (USUHS) via Henry M Jackson Foundation for the Advancement of Military Medicine): Quoc-Dien Trinh leads the BWH team analyzing the current allocation of complex surgical care within the US Military Health System, identifying candidates for centralization and measuring how volume-outcome effect varies among surgical procedures and care settings. The overall goal is to model the potential impact of centralization of complex surgical care on costs and outcomes for the US military health system.