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Pilot study of an implantable microdevice to test multiple drug responses in prostate cancer patients

植入式微型装置的初步研究，用于测试前列腺癌患者的多种药物反应

基本信息

批准号：
10360532
负责人：
Nobuhiko Hata
金额：
$ 66.74万
依托单位：
BRIGHAM AND WOMEN'S HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-03-04 至 2024-02-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10360532
关键词：
Androgens Biological Markers Biology Biomedical Engineering Biopsy Cancer Patient Cessation of life Characteristics Clinical Clinical Research Devices Disease Dose Drug Combinations Drug Exposure Drug Kinetics Effectiveness Ensure Environment Foundations Genetic Genomics Gland Goals Head Heterogeneity Histopathology Hospitals Hour Image Immune response Immunologic Markers Immunologics Implant Individual Lesion Magnetic Resonance Imaging Malignant Neoplasms Malignant neoplasm of prostate Mass Spectrum Analysis Measurement Measures Medical Metastatic Prostate Cancer Methods Multimodal Imaging Needle biopsy procedure Neoadjuvant Therapy Oncology Operative Surgical Procedures Pathology Pathway interactions Patients Pharmaceutical Preparations Pharmacodynamics Pharmacologic Actions Phenotype Physiological Pilot Projects Prediction of Response to Therapy Procedures Prostate Prostate Cancer therapy Prostatic Neoplasms Radical Prostatectomy Regimen Research Research Personnel Resistance Resources Retrieval Role Safety Selection for Treatments Specimen Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization Systemic Therapy Technology Testing Tissues Translating Treatment Protocols Treatment-related toxicity Tumor Markers United States Urology Woman Work cancer care chemotherapy clinically relevant deprivation drug response prediction high risk image guided implantation in vivo individual patient individualized medicine innovation men metabolomics microdevice minimally invasive novel novel therapeutics optimal treatments pilot trial potential biomarker predicting response prostate cancer risk prostate lesions response response biomarker standard of care systemic toxicity targeted treatment tissue biomarkers transcriptome sequencing transcriptomics treatment response treatment strategy tumor tumor heterogeneity

项目摘要

Prostate cancer is the 2nd most common form of cancer among men in United States, in fact, over 26,000 men will die from PCa in the US in 2017. Researchers now believe that prostate cancer specific progression to death can be altered by a more optimal initial treatment strategy that includes systemic treatment. However, there is a paucity of material and research available to optimize the sequence or optimal combination(s) of agents and to maximize the impact of neoadjuvant treatment tailored specifically to the individual patient. This issue is heightened by the recent introduction of new drugs for androgen deprivation, chemotherapy and more recently, targeted therapy of high-risk prostate cancer (PCa). Our long-term goal is to develop an innovative treatment regimen for men with high-risk PCa to treat occult metastatic disease as well as the local tumor, by utilizing neoadjuvant therapy. The objective of this project is to assess the feasibility of implantable microdevices (IMD) to measure local intratumor response to multiple agents. The rationale of the study is that, upon successful completion of this study, we will have shown that we can obtain intratumor efficacy readouts for 19 therapies from a single patient. We will also have established whether these measurements can be used to tailor personalized and specific systemic therapy for a particular patient. With expertise in bioengineering, imaging, pathology, oncology and urology, our team is well prepared to complete this research. We will achieve our goals in the following four specific aims: 1) Develop and clinically validate a device to measure intratumor response to multiple therapies without exposing patients to systemic toxicity; and 2) Demonstrate differential local tumor response to different drugs delivered by IMD; and 3) Examine the role of biomarkers in the treatment response; and 4) To retrieve implanted IMD under MRI guidance using a retrieval device. The proposed research is significant since each tumor responds differently to different agents and lays the foundation for an IMD directed neoadjuvant trial. This will lay the ground work to prove that local intratumor response to micro doses of multiple agents can be used to effectively screen for and tailor the optimal treatment in a novel neo-adjuvant regimen. In addition, by examining the tumor for genetic and physiologic changes, we will be able to in vivo correlate potential biomarkers of tumor response to multiple drugs. Our approach is innovative as the assessment of response occurs within the patient native tumor environment - as such stroma and systemic immune response can be assessed. We will leverage expertise in a precision image guided approach to achieve precise implantation of IMDs into prostate tumors under MRI guidance, and subsequent retrieval during planned surgery.

前列腺癌是美国男性中第二常见的癌症，事实上，超过26000名男性会患前列腺癌