The significance of the proposed research is based on the growing demand for healthcare resources to treat and manage prostatic disease, particularly benign prostatic hyperplasia (BPH) and cancer. Both the incidence and cost of treatment for BPH, and its complications, are growing rapidly with the aging U.S. population;prostate cancer is the second-leading cause of cancer deaths among men in the U.S. There is a clear need for minimally invasive, cost-effective therapies to match the outcomes of surgical treatment options, which are associated with significant morbidity and complications. Prostate injections have not become standard of care due to inadequate drug distribution with needles. The Applicants have developed a microporous hollow fiber catheter (MiHFC) for improved injection distribution in the prostate. Phase II innovations focus on further developing MiHFC and combining existing treatment planning methods for drug delivery injections into human prostates with the objective to develop a system that is ready for human clinical use. The same MiHFC device with small changes would be adaptable for use in many other human clinical applications needing improved injection systems, such as liver, kidney and other solid organs. This would allow researchers to use MiHFC devices for other research projects involving human drug injections, either with or without treatment planning. Hypothesis: The MiHFC injection system being developed in Phase II will give urologists and researchers a more reliable tool to plan and deliver injection therapies into the human prostate. Preliminary Data: In Phase I research, the innovative use of applicant's MiHFC to improve injection drug delivery into the prostate was successful with MiHFC significantly improving ethanol distribution in canine prostates as compared to needle injections.
Specific Aims : The objective of this Phase II proposal is to further develop the applicant's innovative drug delivery system for improved prostate disease therapies and to provide the bench and animal study data to accelerate its clinical use.
Aim 1 : Finalize human use MiHFC design. The Phase I MiHFC design will be optimized to meet human use specifications established from user requirements.
Aim 2 : Infusion studies and analysis. Human ex vivo and baboon in vivo studies will be conducted to assess MiHFC safety and agent distribution and to develop of a prostate specific treatment planning system.
Aim 3 : Design verification and 510(k) submission. Design verification test data and FDA 510(k) clearance will facilitate clinical adoption and commercialization.
There is a significant demand for healthcare resources to treat and manage prostate diseases. The objective of this Phase II proposal is to develop an innovative drug delivery system for improved prostate disease therapies and to provide the bench and animal study data to accelerate its clinical use.