Evaluation of novel treatments in biochemically recurrent prostate

生化复发性前列腺新疗法的评价

• 批准号: 10926385
• 负责人: Ravi Madan
• 金额: $ 36.43万
• 依托单位: DIVISION OF BASIC SCIENCES - NCI
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10926385
• 关键词: Agreement; Androgen Antagonists; Area; Biochemical; COVID-19 pandemic; Cancer Patient; Castrate sensitive prostate cancer; Cells; Clinical; Clinical Trials; Collaborations; Combination immunotherapy; Data; Data Analyses; Development; Evaluation; FDA approved; Future; Goals; Image; Immune; Immunologics; Immunotherapy; Industry; Investigational Therapies; Kinetics; Malignant neoplasm of prostate; National Institute of Arthritis, and Musculoskeletal, and Skin Diseases; Nonmetastatic; Outcome; Patients; Phase; Population; Positron-Emission Tomography; Prostate; Protocols documentation; Publications; Quality of Life Assessment; Quality of life; Radiation; Radiopharmaceuticals; Radium; Recurrence; Safety; Science; Surveys; androgen deprivation therapy; castration resistant prostate cancer; cohort; enzalutamide; follow-up; microbiome; novel; phase II trial

Two protocols have been completed. 13-c-0153: Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer has completed the data analysis phase and is pending publication. Enzalutamide alone extends PSA suppression in patients with non-metastatic castration resistant prostate cancer and future studies are planned ti further evaluate this. Furthermore, immune changes were noted after enzalutamide therapy as well. 16-c-0035: Prostvac in Patients With Biochemically Recurrent Prostate Cancer: This study has completed accrual at the NCI, Dana Farber and Sloan Kettering and is now being prepared for publications. Of note, late PSA declines were seen in 15-20% of patients. 18-c-0005: Phase II Trial of Combination Immunotherapy in Biochemically Recurrent Prostate Cancer: This study has completed the safety phase of the trial and now is in the main cohort of non-metastatic castration resistant prostate cancer patients and is accruing at the NCI. We are approximately 2/3 of the way through accrual and expect to compete accrual in the next 6-10 months. 20-c-0010 Radium 233 in biochemically recurrent prostate cancer is evaluating the immune impact of an FDA-approved radiopharmaceutical in patients with micro-metastatic (only PET scan positive) prostate cancer. This study had its accrual held through much of the COVID pandemic but is now approximately 1/3 of the way through accrual with rapid accrual in recent months. Additional studies are being planned with other non-toxic immunotherapy strategies. The uniform use of PET imaging is part of the GMB's programmatic approach to developing clinical trials in BCRpc. All current and future BCRpc studies are evaluating the impact of PSA kinetics on these patients using validated quality of life survey. In addition, the immunologic impact of these treatments on circulating immune cell subsets. And in a collaboration with Dr. Heidi Kong of NIAMS, we are evaluating the microbiome to better understand how baseline the microbiome may be associated with clinical outcomes while also evaluating the influence of experimental therapies on the microbiome in BCRpc.

两个协议已经完成。 13-c-0153：恩杂鲁胺与 PSA-TRICOM 联合治疗非转移性去势敏感前列腺癌患者已完成数据分析阶段，正在等待发表。单独使用恩杂鲁胺可以延长非转移性去势抵抗性前列腺癌患者的 PSA 抑制，并且计划进行未来的研究以进一步评估这一点。此外，恩杂鲁胺治疗后也发现了免疫变化。 16-c-0035：Prostvac 用于生化复发性前列腺癌患者：这项研究已在 NCI、Dana Farber 和 Sloan Kettering 完成了收集，目前正在准备发表。值得注意的是，15-20% 的患者出现晚期 PSA 下降。 18-c-0005：生化复发性前列腺癌联合免疫疗法的 II 期试验：该研究已完成试验的安全阶段，目前属于非转移性去势抵抗性前列腺癌患者的主要队列，并正在 NCI 进行累积。我们的应计工作已完成大约 2/3，预计在未来 6-10 个月内完成应计工作。 20-c-0010 生化复发性前列腺癌中的镭 233 正在评估 FDA 批准的放射性药物对微转移（仅 PET 扫描阳性）前列腺癌患者的免疫影响。这项研究在新冠疫情期间的大部分时间里都保持了应计，但现在大约是应计的 1/3，而且近几个月来快速应计。正在计划针对其他无毒免疫治疗策略进行更多研究。统一使用 PET 成像是 GMB 在 BCRpc 中开发临床试验的计划方法的一部分。所有当前和未来的 BCRpc 研究都正在使用经过验证的生活质量调查来评估 PSA 动力学对这些患者的影响。此外，这些治疗对循环免疫细胞亚群的免疫影响。通过与 NIAMS 的 Heidi Kong 博士合作，我们正在评估微生物组，以更好地了解微生物组基线与临床结果的关系，同时评估 BCRpc 中实验疗法对微生物组的影响。

项目成果

Clinical and immunologic impact of short-course enzalutamide alone and with immunotherapy in non-metastatic castration sensitive prostate cancer.

• DOI: 10.1136/jitc-2020-001556
• 发表时间: 2021-03
• 期刊: Journal for immunotherapy of cancer
• 影响因子: 10.9
• 作者: Madan RA;Karzai F;Donahue RN;Al-Harthy M;Bilusic M;Rosner II;Singh H;Arlen PM;Theoret MR;Marté JL;Cordes L;Couvillon A;Hankin A;Williams M;Owens H;Lochrin SE;Chau CH;Steinberg S;Figg WD;Dahut W;Schlom J;Gulley JL
• 通讯作者: Gulley JL

The Potential Role for Immunotherapy in Biochemically Recurrent Prostate Cancer.

• DOI: 10.1016/j.ucl.2020.07.004
• 发表时间: 2020-11
• 期刊: The Urologic clinics of North America
• 作者: Bilusic M;Einstein DJ;Karzai FH;Dahut WL;Gulley JL;Aragon-Ching JB;Madan RA
• 通讯作者: Madan RA

The Continuum of Metastatic Prostate Cancer: Interpreting PSMA PET Findings in Recurrent Prostate Cancer.

• DOI: 10.3390/cancers14061361
• 发表时间: 2022-03-08
• 期刊: Cancers
• 影响因子: 5.2
• 作者: Kase AM;Tan W;Copland JA 3rd;Cai H;Parent EE;Madan RA
• 通讯作者: Madan RA