PHASE II, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PROSTVAC (PSA-TRICOM) IN PATIENTS... (PROTOCOL UAZ2012-03-01). CONTRACTOR: UNIVERSITY OF ARIZONA. CONTRACT: HHSN261201200031I. PERIOD: 9

PROSTVAC (PSA-TRICOM) 在患者中的 II 期、随机、安慰剂对照试验...（方案 UAZ2012-03-01）。

• 批准号: 10207321
• 负责人: SHERY CHOW
• 金额: $ 16.85万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-12 至 2020-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10207321
• 关键词: Arizona; Benign; CD8B1 gene; Cells; Clinical; Contractor; Contracts; Data; Double-blind trial; Evaluation; Exercise; Immune; Immunologics; Intervention; Magnetic Resonance Imaging; Malignant - descriptor; Malignant neoplasm of prostate; PSA level; Participant; Patients; Phase; Placebos; Randomized; Stains; Subgroup; Time; Tissues; Tumor Tissue; Universities; Vaccines; post intervention; primary endpoint; programmed cell death ligand 1; prostate biopsy; randomized placebo controlled trial; response; safety and feasibility; serum PSA; tumor

The contractor will conduct a phase II randomized, placebo-controlled, double-blind trial of PROSTVAC in patients with clinically localized prostate cancer undergoing active surveillance to assess the immunological (primary) and clinical (secondary) response to this vaccine.

承包商将对接受主动监测的临床局限性前列腺癌患者进行 PROSTVAC II 期随机、安慰剂对照、双盲试验，以评估对该疫苗的免疫（初级）和临床（次级）反应。