PSMA-PET to Guide Prostatectomy: Can PSMA-PET Appropriately Modify Surgery, Reduce Nerve Damage and Optimize Quality-of-Life?

PSMA-PET 指导前列腺切除术：PSMA-PET 能否适当修改手术、减少神经损伤并优化生活质量？

• 批准号: 10580040
• 负责人: Clinton David Bahler
• 金额: $ 59.52万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-01 至 2027-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10580040
• 关键词: Aftercare; Antigen Targeting; Biopsy; Blinded; Cancer Control; Cancer Death Rates; Cancer Patient; Clinical; Control Groups; Detection; Disease; Drops; Enrollment; Ensure; Erectile dysfunction; European; Excision; Extraprostatic; FOLH1 gene; Fire - disasters; Friends; Goals; Image; Image-Guided Surgery; Imaging technology; Incontinence; Individual; Life Experience; Location; Magnetic Resonance Imaging; Malignant Neoplasms; Malignant neoplasm of prostate; Measures; Metastatic Prostate Cancer; Microscopic; Mission; Modality; Modification; Molecular Target; Monitor; Muscle; Nerve; Newly Diagnosed Disease; Operative Surgical Procedures; Outcome; Outcome Measure; Pathology; Patient-Focused Outcomes; Patients; Pelvis; Performance; Phase; Phase II Clinical Trials; Population; Positron-Emission Tomography; Prostate; Prostatectomy; Public Health; Quality of life; Radiation therapy; Radiology Specialty; Radiopharmaceuticals; Randomized; Randomized, Controlled Trials; Reader; Recurrence; Recurrent Malignant Neoplasm; Regrets; Reporting; Research; Research Personnel; Risk; Side; Structure; Structure of capsule of prostate; Surgeon; Surgical margins; Survivors; Testing; Tracer; Treatment Side Effects; Tumor Markers; United States National Institutes of Health; Urinary Incontinence; Validation; cancer recurrence; cancer surgery; clinical care; comparison group; disorder control; improved; innovation; lymph nodes; nerve damage; predictive tools; preservation; prostate cancer survivors; randomized trial; side effect; spared nerve; standard of care; targeted agent; tool; treatment planning; urinary; whole body imaging

Project Summary/Abstract The 68Ga-P16-093 radiopharmaceutical is an investigational agent that targets prostate specific membrane antigen (PSMA), which is highly expressed in most prostate cancers. PSMA-PET has not been validated as a tool for guiding surgical resection of primary prostate cancer. The objective of this Phase II Clinical Trial is to critically test the ability of 68Ga-P16-093 PET to identify extra- prostatic extension of prostate cancer, to guide surgical resection, and to improve the patient’s post-surgical quality-of-life. For prostate cancer patients who require prostatectomy, we hypothesize that PSMA-PET findings will accurately differentiate patients who can safely undergo nerve-sparing and/or muscle-sparing surgery from those in whom more aggressive wide resection is essential for cancer control; thus, optimizing quality-of-life outcomes. Therefore, the project has two complementary yet independent Specific Aims: Aim 1. To measure the accuracy of both 68Ga-P16-093 PET-CT, and conventional standard-of-care mpMRI, for presurgical detection of extra-prostatic extension. Aim 2. To measure treatment modifications, and patient quality-of-life outcomes, that result from 68Ga- P16-093 -PET incorporation into surgical planning. The innovations of this project are the application of this imaging technology in pre-surgical treatment planning for newly diagnosed disease; the definitive assessment of agent performance in a surgical randomized controlled trial; and the detailed assessments of imaging impact on both surgical planning and subsequent patient clinical outcome. As a control group, one-half of the enrolled subjects will receive their standard-of-care prostatectomy with surgical planning supported only by multiparametric MRI and biopsy findings. The other half of the subjects will be randomized to also receive pre-surgical pelvic imaging with 68Ga-P16-093 PET/CT for independent assessment of the location and extent of disease. The radiology MRI and PET readers will be blinded to the findings of the other modality. The surgeon will receive reports on all imaging, but must document a standard-of-care surgical plan before receiving the PET findings. The surgeon will then document whether, and how, the PET information modifies their prior surgical plan. For validation of imaging findings, whole mount pathology will serve as the “gold standard” for characterization of disease. Patient outcome measures, and cancer recurrence, will be tracked for 18-months following surgery. Our preliminary studies indicate 68Ga-P16-093 PET-CT will show higher accuracy than mpMRI for detection of extra-prostatic extension. And, that the PET-directed surgical modifications will frequently result in appropriate preservation of nerves and muscle, thereby improving post-treatment quality-of-life for many patients, while also helping to avoid positive surgical margins.

项目摘要/摘要 68GA-P16-093放射性药物是一种针对前列腺特异性膜的研究剂 抗原（PSMA），在大多数前列腺取消器中都高度表达。 PSMA-PET尚未被证实为 指导原发性前列腺癌手术切除的工具。 该II期临床试验的目的是严格测试68GA-P16-093 PET鉴定外部的能力 前列腺癌的前列腺延伸，指导外科切除并改善患者的后手术 生活质量。对于需要前列腺切除术的前列腺癌患者，我们假设PSMA-PET 调查结果将准确区分可以安全地经历紧张和/或肌肉比较紧张的患者 从更具侵略性的大切除对癌症控制至关重要的人的手术；因此，优化 生活质量的结果。因此，该项目具有两个完整而独立的特定目标： 目标1。测量68GA-P16-093 PET-CT和常规标准护理的准确性 mpMRI，用于术前检测外延伸。 目的2。测量治疗修改和患者的生活质量结果，这是由68GA-造成的 P16-093 -PET纳入外科计划。 该项目的创新是该成像技术在外科治疗中的应用 计划新诊断的疾病；手术随机分析中对代理性能的确切评估 对照试验；以及对成像对手术计划和随后的影响的详细评估 患者临床结果。作为对照组，注册受试者的一半将获得护理标准 前列腺切除术和手术计划仅由多参数MRI和活检结果支持。另一个 一半的受试者将被随机分配，也将接受手术前的骨盆成像68GA-P16-093 PET/CT 用于独立评估疾病的位置和程度。放射学MRI和宠物读者将是 对另一种方式的发现视而不见。外科医生将收到有关所有成像的报告，但必须 在收到宠物发现之前，请记录标准的手术计划。然后，外科医生将记录 宠物信息是否以及如何修改其先前的手术计划。用于验证成像发现， 整个坐骑病理学将作为疾病表征的“黄金标准”。病人的结果 手术后，将追踪18个月的措施和癌症复发。我们的初步研究 指出68GA-P16-093 PET-CT将显示出比MPMRI更高的准确性 扩大。并且，以宠物为导向的手术修饰将经常导致适当的保存 神经和肌肉，从而改善了许多患者的治疗后生活质量，同时也有助于 避免阳性手术边缘。