Positron Emission Tomography in Prostate Cancer

描述(由申请人提供)： 该项目的主要目标是确定使用放射性药物C-11醋酸酯(AC-PET)的正电子发射断层扫描在中高风险前列腺癌患者中的价值，这些患者是根治性前列腺癌切除术或放射治疗的候选治疗对象，因为标准的临床和影像评估显示肿瘤是否扩散到前列腺以外。将追求以下具体目标：1.确定AC-PET在改变初始患者处理方面的作用；2.确定AC-PET在预测复发方面的价值；3.通过与活检的比较，评估AC-PET在检测淋巴结方面的性能。研究设计：这项研究包括两组共285名患者，他们计划接受有治疗意图的治疗，两人都将在治疗前接受AC-PET成像。对于手术组，如果PET检查在前列腺癌以外的疾病中呈阴性，治疗将继续进行，并将跟踪患者以寻找复发的证据。如果PET检查呈阳性，将鼓励转诊医生进行验证性研究，这可能会导致治疗方法的改变。放射治疗组的所有患者都将接受标准治疗，然后将对他们进行跟踪，以寻找复发的证据。将手术患者的淋巴结活检结果与PET结果进行对照，计算AC-PET的阳性预测值和阴性预测值。预期结果：AC-PET将导致至少10%的手术患者取消根治性前列腺切除术。与基于临床分期、PSA和Gleason评分的传统方法相比，AC-PET对复发的预测也有望显著提高。AC-PET与病理对照时，应具有较高的预测价值。健康相关性：如果该项目成功，它将对中高风险前列腺癌患者的管理产生重大影响，这些患者是治疗的候选对象。在其中一些患者中，PET扫描呈阳性将导致计划中的手术取消，使这些患者避免根治性手术的发病率，同时允许他们中的一些人接受更适当的激素治疗。PET还可以提供重要的预后信息，这些信息可能会影响早期辅助治疗的决定，以延迟或防止复发。

DESCRIPTION (provided by applicant): The primary goal of this project is determination of the value of positron emission tomography employing the radiopharmaceutical C-11 acetate (AC-PET) in patients with medium- and high-risk prostate cancer who are candidates for treatment with curative intent by radical prostatectomy or radiation therapy because the standard clinical and imaging evaluation was negative for tumor spread beyond the prostate. The following specific aims will be pursued: 1. Determine the role of AC-PET in changing initial patient management; 2. Determine the value of AC-PET in predicting recurrence; 3. Assess the performance of AC-PET for detection of lymph nodes by comparison with biopsy. Study Design: The study includes a total of 285 patients in two groups who are scheduled for treatment with curative intent, both of whom will undergo AC-PET imaging prior to treatment. For the surgery group, if the PET examination is negative for disease outside the prostate gland, the treatment will proceed and the patient will be followed for evidence of recurrence. If the PET examination is positive, the referring physician will be encouraged to undertake confirmatory studies, which may lead to a change in therapy. All patients in the radiation therapy group will undergo the standard treatment, and they will then be followed for evidence of recurrence. The lymph node biopsy results in the surgery patients will be correlated with the PET findings to compute the positive and negative predictive values of AC-PET. Anticipated Results: AC-PET will lead to cancellation of radical prostatectomy in at least 10% of the surgical patients. It is also expected that AC-PET will significantly improve the prediction of recurrence compared with conventional methods based on clinical stage, PSA and Gleason score. The predictive value of AC-PET should be high when correlated with the pathological data. Health Relevance: If this project is successful, it will have a significant impact on the management of patients with moderate- and high-risk prostate cancer who are candidates for curative treatment. In some of these patients, a positive PET scan will lead to cancellation of planned surgery, sparing these men the morbidity of radical surgery while permitting some of them to receive more appropriate hormonal treatment. PET may also contribute significant prognostic information that may affect the decision to administer early adjuvant therapy to delay or prevent recurrence.