Clinical Research
The clinical research team manages upwards of 20 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 department supports.
Examples of our current studies include:
Sponsor-Initiated Trials
- A Phase 2, Open-Label Study to Evaluate the Safety and Anti-Tumor Activity of Intravesical Instillation of TARA-002 in Adults with High-Grade Non-Muscle Invasive Bladder Cancer (ADVANCED-2): Timothy Clinton is leading this Protara Therapeutics, Inc. sponsored trial, testing the anti-tumor activity (how well the study drug is working on cancer), and the safety of an investigational study drug called TARA-002, for high-grade non-muscle invasive bladder cancer (NMIDC).
- A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination with Cetrelimab and Cetrelimab Alone in Participants with Muscle-Invasive Urothelial Carcinoma of the Bladder who are Scheduled for Radical Cystectomy and are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy (SunRISe-4): Mark Preston leads this trial, studying a TAR-200 device (drug-delivery system) that is placed transurethrally and removed during an in-office cystoscopy. This device is designed to deliver gemcitabine (cancer medicine) intravesically to the bladder while the device is placed.
Investigator Initiated Trials
- Polygenic Risk Stratification Combined with mpMRI to Identify Clinically Relevant Prostate Cancer: Adam Kibel, in collaboration with the National Cancer Institute (NCI), has been awarded a U01 grant to study if genetic data can be used along with Magnetic Resonance Imaging (MRI) to improve our ability to detect prostate cancer. Dr. Kibel is serving as the sponsor-investigator for this trial, and participants will be recruited at our site from the Mass General Brigham (MGB) Biobank as well as within BWH Primary Care Offices. Walter Reed National Military Medical Center and Howard University Hospital will also be recruiting participants for this study, and analysis is being assisted by the Harvard T.H. Chan School of Public Health. More information on this trial can be found at ClinicalTrials.gov, using the ID: NCT06398639.
- 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 for evaluating drug responses in situ in prostate cancer (Supported by NIH/NCI, Pfizer): 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. In November of 2023, WCVB featured a story on the Implantable Microdevice for Prostate Cancer trial. More information on this trial can be found at ClinicalTrials.gov, using the ID: NCT04399876.
Translational Research
- Dr. Li Jia’s lab has been developing novel therapeutic approaches to target DNA repair pathway in prostate cancer (funded by DoD and NIHR01). Genomic research has identified several molecular targets in metastatic castration-resistant prostate cancer (mCRPC) beyond the androgen receptor (AR). One common type of genetic change involves genes responsible for repairing DNA damage. These changes can make cancer cells particularly vulnerable to certain treatments. For example, when the homologous recombination repair (HRR) process is defective, cancer cells become more sensitive to drugs called PARP inhibitors, like olaparib and rucaparib, which the FDA has approved for treating mCRPC patients with specific mutations in HRR genes, especially BRCA1 and BRCA2. Tumors with these mutations often respond very well to PARP inhibitors. However, changes in other DNA repair genes don’t always predict the same response. Currently, the use of PARP inhibitors mainly focuses on single gene mutations, ignoring other possible genetic alterations. To address this, our project used genome-wide CRISPR screening to identify new genes, such as RNASEH2B and MMS22L, that affect the response to PARP inhibitors. Our goal is to identify patients who could benefit from PARP inhibition beyond those harboring BRCA1/2 mutations.
Health Services Research
- 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, identify candidates for centralization and measure 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.
Research Laboratories
