PDF(Pubmed)
Abstract：
UNASSIGNED: In active surveillance there is significant interest in whether imaging modalities such as multiparametric magnetic resonance imaging (mpMRI) or 68Gallium prostate-specific membrane antigen positron emission tomography/computerized tomography (68Ga-PSMA-PET/CT) can improve the detection of progression to clinically significant prostate cancer (csPCa) and thus reduce the frequency of prostate biopsies and associated morbidity. Recent studies have demonstrated the value of mpMRI in active surveillance; however, mpMRI does miss a proportion of disease progression and thus alone cannot replace biopsy. To date, prostate-specific membrane antigen positron emission tomography (PSMA-PET) has shown additive value to mpMRI in its ability to detect prostate cancer (PCa) in the primary diagnostic setting. Our objective is to evaluate the diagnostic utility of PSMA-PET to detect progression to csPCa in active surveillance patients.
UNASSIGNED: We will perform a prospective, cross-sectional, partially blinded, multicentre clinical trial evaluating the additive value of PSMA-PET with mpMRI against saturation transperineal template prostate biopsy. Two hundred and twenty-five men will be recruited who have newly diagnosed PCa which is suitable for active surveillance. Following enrolment, patients will undergo a PSMA-PET and mpMRI within 3 months of a repeat 12-month confirmatory biopsy. Patients who remain on active surveillance after confirmatory biopsy will then be planned to have a further mpMRI and PSMA-PET prior to a repeat biopsy in 3-4 years. The primary outcome is to assess the ability of PSMA-PET to detect or exclude significant malignancy on repeat biopsy. Secondary outcomes include (I) assess the comparative diagnostic accuracies of mpMRI and PSMA-PET alone [sensitivity/specificity/negative predictive value (NPV)/positive predictive value (PPV)] to detect progression on biopsy based on predefined histologic criteria for progression; (II) comparison of index lesion identification by template biopsies vs. MRI targeted lesions vs. PSMA targeted lesions; (III) evaluation of concordance of lesions identified on final histopathology and each imaging modality (PSMA-PET and/or mpMRI) in the subset of patients proceeding to RP.
UNASSIGNED: The results of this trial will define the role of PSMA-PET in active surveillance and potentially reduce the number of biopsies needed to detect progression to csPCa.
UNASSIGNED: The current trial was registered with the ANZCTR on the 3/2/2022 with the trial ID ACTRN12622000188730, it is accessible at https://www.anzctr.org.au/.
UNASSIGNED: We will perform a prospective, cross-sectional, partially blinded, multicentre clinical trial evaluating the additive value of PSMA-PET with mpMRI against saturation transperineal template prostate biopsy. Two hundred and twenty-five men will be recruited who have newly diagnosed PCa which is suitable for active surveillance. Following enrolment, patients will undergo a PSMA-PET and mpMRI within 3 months of a repeat 12-month confirmatory biopsy. Patients who remain on active surveillance after confirmatory biopsy will then be planned to have a further mpMRI and PSMA-PET prior to a repeat biopsy in 3-4 years. The primary outcome is to assess the ability of PSMA-PET to detect or exclude significant malignancy on repeat biopsy. Secondary outcomes include (I) assess the comparative diagnostic accuracies of mpMRI and PSMA-PET alone [sensitivity/specificity/negative predictive value (NPV)/positive predictive value (PPV)] to detect progression on biopsy based on predefined histologic criteria for progression; (II) comparison of index lesion identification by template biopsies vs. MRI targeted lesions vs. PSMA targeted lesions; (III) evaluation of concordance of lesions identified on final histopathology and each imaging modality (PSMA-PET and/or mpMRI) in the subset of patients proceeding to RP.
UNASSIGNED: The results of this trial will define the role of PSMA-PET in active surveillance and potentially reduce the number of biopsies needed to detect progression to csPCa.
UNASSIGNED: The current trial was registered with the ANZCTR on the 3/2/2022 with the trial ID ACTRN12622000188730, it is accessible at https://www.anzctr.org.au/.
摘要：
■在主动监测中，对成像方式（例如多参数磁共振成像（mpMRI）或68镓前列腺特异性膜抗原正电子发射断层扫描/计算机断层扫描（68Ga-PSMA-PET/CT）是否可以改善对临床上有意义的前列腺癌（csPCa）进展的检测，从而降低前列腺活检的频率和相关的发病率，具有重要意义。最近的研究已经证明了MPMRI在主动监测中的价值；然而，mpMRI确实错过了一部分疾病进展，因此不能单独代替活检。迄今为止,前列腺特异性膜抗原正电子发射断层扫描（PSMA-PET）在主要诊断环境中检测前列腺癌（PCa）的能力方面已显示出对mpMRI的附加价值。我们的目标是评估PSMA-PET在主动监测患者中检测csPCa进展的诊断实用性。
■我们将执行一个预期的，横截面,部分失明,多中心临床试验评估PSMA-PET与mpMRI对饱和经会阴模板前列腺活检的累加价值。将招募二百二十五名男性，他们新诊断出适合主动监测的PCa。入学后，患者将在12个月再次确诊活检后3个月内接受PSMA-PET和mpMRI检查.在确诊活检后仍保持主动监测的患者将计划在3-4年内进行进一步的mpMRI和PSMA-PET，然后进行重复活检。主要结果是评估PSMA-PET在重复活检中检测或排除明显恶性肿瘤的能力。次要结果包括(I)评估单独的mpMRI和PSMA-PET的比较诊断准确性[敏感性/特异性/阴性预测值(NPV)/阳性预测值(PPV)]，以根据预定义的组织学进展标准检测活检进展MRI靶向病变与PSMA靶向病变;(III)评估在进行RP的患者亚组的最终组织病理学和每种成像模式(PSMA-PET和/或mpMRI)上确定的病变的一致性。
■该试验的结果将确定PSMA-PET在主动监测中的作用，并可能减少检测csPCa进展所需的活检数量。
■当前的试验已在3/2/2022的ANZCTR注册，试验ID为ACTRN12622000188730，可通过https://www访问。anzctr.org.au/.
■我们将执行一个预期的，横截面,部分失明,多中心临床试验评估PSMA-PET与mpMRI对饱和经会阴模板前列腺活检的累加价值。将招募二百二十五名男性，他们新诊断出适合主动监测的PCa。入学后，患者将在12个月再次确诊活检后3个月内接受PSMA-PET和mpMRI检查.在确诊活检后仍保持主动监测的患者将计划在3-4年内进行进一步的mpMRI和PSMA-PET，然后进行重复活检。主要结果是评估PSMA-PET在重复活检中检测或排除明显恶性肿瘤的能力。次要结果包括(I)评估单独的mpMRI和PSMA-PET的比较诊断准确性[敏感性/特异性/阴性预测值(NPV)/阳性预测值(PPV)]，以根据预定义的组织学进展标准检测活检进展MRI靶向病变与PSMA靶向病变;(III)评估在进行RP的患者亚组的最终组织病理学和每种成像模式(PSMA-PET和/或mpMRI)上确定的病变的一致性。
■该试验的结果将确定PSMA-PET在主动监测中的作用，并可能减少检测csPCa进展所需的活检数量。
■当前的试验已在3/2/2022的ANZCTR注册，试验ID为ACTRN12622000188730，可通过https://www访问。anzctr.org.au/.
