PHASE I-II STUDY ON HSV-TK GENE THERAPY + RADIOTHERAPY FOR PROSTATE CANCER

HSV-TK 基因治疗前列腺癌放射治疗的 I-II 期研究

• 批准号: 7375023
• 负责人: E BRIAN BUTLER
• 金额: $ 0.19万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7375023
• 关键词: PHASE; II; STUDY; HSV; TK

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a prospective phase I-II study to assess the efficacy and toxicity of HSV-tk+ valacyclovir gene therapy in combination with radiotherapy in previously untreated prostate cancer. This study is comprised of three arms (see below for subject population criteria). Arm A will include low risk patients (with favorable prognostic factors) while arm B will have high risk patients (with unfavorable prognostic factors). Arm C is comprised of patients with pathologic proven iliac lymph node metastasis (Stage D1). Arms B and C patients will receive neoadjuvant androgen ablation as part of their standard of care. Clinical response as evaluated by changes in serum PSA level and digital rectal examination as well as by histological alterations on re-biopsy such as the presence of apoptosis, necrosis, tumor proliferation and immunologic response, will be assessed following HSV-tk + valacyclovir treatment. Blood samples are also taken for assessment of systemic immunological response. Serum testosterone will be measured. Additionally, patients will be followed closely to assess nadir PSA, freedom from PSA-progression, and freedom from local and distant progression and overall survival.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中得到体现。列出的机构是中心的机构，不一定是研究者的机构。这是一项前瞻性 I-II 期研究，旨在评估 HSV-tk+ 伐昔洛韦基因疗法与放射疗法联合治疗先前未经治疗的前列腺癌的疗效和毒性。这项研究由三个组组成（有关受试者群体标准，请参阅下文）。 A 组将包括低风险患者（具有有利的预后因素），而 B 组将包括高风险患者（具有不利的预后因素）。 C 组由病理证实有髂淋巴结转移（D1 期）的患者组成。 B 组和 C 组患者将接受新辅助雄激素消融作为其标准护理的一部分。 HSV-tk + 伐昔洛韦治疗后，将通过血清 PSA 水平和直肠指检的变化以及重新活检时的组织学改变（例如细胞凋亡、坏死、肿瘤增殖和免疫反应的存在）来评估临床反应。还采集血样以评估全身免疫反应。将测量血清睾酮。此外，还将密切跟踪患者，以评估最低 PSA、无 PSA 进展、无局部和远处进展以及总体生存率。