FY20 SBIR PHASE I TOPIC #400 - AMBAY RADI-SENSE: NON-INVASIVE, NOVEL TEST TO MONITOR BIOLOGICAL RESPONSE TO RADIOTHERAPY

放疗是前列腺癌的主要治疗方式，前列腺癌是最常见的恶性肿瘤，也是男性癌症相关死亡的第二大原因。尽管放射治疗在治疗器官受限/局限性晚期前列腺癌方面具有治愈潜力，但50%的患者经历了疾病复发。目前的方法是用“一刀切”的疗法来治疗患者，但未能取得良好的效果。本提案的目标是开发一种基于非侵入性（人类血清）生物标志物的测试，“radii - sense”，以个性化放疗，可以指导临床医生为患者开发新的治疗方案。患者对放疗的反应将通过监测导致放疗失败的细胞通路中基因表达的变化来分析。提出的方法将(i)从根本上改变目前测量肿瘤大小变化以评估放射治疗反应的临床标准；（ii）协助设计有效的治疗方案，而无需进行活检/连续活检；（iii）在放射治疗之前、期间和之后进行监测和抽样；（iv）在早期治疗阶段，可为高危患者提供合适的替代治疗，并为不太敏感患者的肿瘤增加剂量；(v)引入与放射治疗联合使用其他方式（例如免疫治疗、分子靶向治疗）的可能性。

Radiotherapy is a major curative treatment modality for prostate cancer, the most common malignancy and the second-leading cause of cancer-related death in men. Despite the curative potential of radiotherapy in treating organ-confined/localized advanced prostate cancer, 50% of the patients experience recurrence of the disease. The current approach, treating patients with "one-size-fits-all" therapy, has failed to deliver favorable results. The goal of this proposal is to develop a non-invasive (human serum) biomarker(s) based test, “RADI-Sense” to personalize radiotherapy, which can guide clinicians to develop new therapeutic regimes for patients. The patients’ response to radiotherapy will be analyzed by monitoring the changes in the expression of genes from cellular pathways leading to failure of radiotherapy. The proposed approach will (i) radically transform the current clinical standard of measuring changes in tumor size to assess response to radiotherapy; (ii) aid in designing effective treatment regimens without the need of biopsy/serial biopsies; (iii) enable monitoring and sampling prior to, during and after radiation treatment; (iv) will enable suitable alternative treatments to high-risk patients and dose escalation to tumors in less sensitive patients during early phases of treatment; (v) introduce the possibility of using other modalities (e.g. immunotherapy, molecular targeted therapy) in combination with radiotherapy.