Saddle Brook

Researchers are evaluating the use of aglatimagene besadenovec combined with valacyclovir in men with localized, intermediate-risk prostate cancer who are planning to undergo external beam radiation therapy (EBRT). This phase 2a, open-label, multi-center study aims to understand how the treatment spreads in the body and its impact on immune system markers. The study focuses on men with intermediate-risk prostate cancer and compares a treatment group receiving the gene therapy plus valacyclovir alongside EBRT to a control group receiving EBRT alone. Participants in the treatment group will receive three intraprostatic injections of aglatimagene besadenovec, a genetically modified virus carrying a specific gene, administered either through the rectum or perineum. Each injection is followed by a 14-day course of oral valacyclovir. EBRT will begin after the second injection. The control group will receive standard or moderately hypofractionated prostate-only EBRT without the gene therapy. Biospecimens such as blood, urine, and semen will be collected at specific times before and after injections to track the presence of the virus and measure immune responses. Participants will be monitored closely throughout the study. Researchers will regularly evaluate safety by tracking adverse events and laboratory tests. The main outcome measured is the biodistribution of aglatimagene besadenovec up to three months after the last injection. Immune system activation markers, viral shedding in various body fluids, and tumor-related proteins will also be assessed. The study involves approximately 45 men divided between the treatment and control groups, with continuous safety monitoring during and after treatment.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.