Wang Jiarou, Li Linlin, Feng Tianrui, Wang Rongxi, Xiang Jialin, Luo Yaping, Zhu Lin, Kung Hank F, Yan Weigang, Zhu Zhaohui
Department of Nuclear Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College.
State Key Laboratory of Complex Severe and Rare Diseases.
Clin Nucl Med. 2025 Jun 1;50(6):517-522. doi: 10.1097/RLU.0000000000005883. Epub 2025 May 5.
Accurate diagnosis of bone metastases in prostate cancer is essential for staging, prognosis, and treatment. Although PSMA PET/CT is highly effective, complementary imaging is needed to clarify indeterminate lesions. The novel bisphosphonate-based agent [68Ga]Ga-P15-041 shows superior diagnostic accuracy over conventional SPECT imaging, indicating its potential as an auxiliary diagnostic tool. This study explores its role in detecting and assessing prostate cancer bone metastases.
This prospective study enrolled 35 patients with prostate cancer and skeletal metastases, who underwent both [68Ga]Ga-P15-041 and [68Ga]Ga-PSMA-11 PET/CT within 1 week. Lesions detected by [68Ga]Ga-PSMA-11 PET/CT were classified using Prostate-specific Membrane Antigen Reporting and Data System 2.0.
[68Ga]Ga-P15-041 PET/CT detected more lesions than [68Ga]Ga-PSMA-11 PET/CT (525 vs 509, P < 0.001) and demonstrated significantly higher tracer uptake, with a mean SUV of 20.73 ± 14.67 compared with 11.13 ± 8.12 (P < 0.0001). It detected significantly more osteoblastic lesions (504 vs 391, P < 0.0001). In addition, this study established the Reporting and Data System for [68Ga]Ga-P15-041 (P15-041-RADS), which classifies prostate cancer bone metastases into 5 categories based on SUVmax and morphologic changes. P15-041-RADS reclassified 85.71% of Prostate-specific Membrane Antigen Reporting and Data System category 3 lesions and 95.00% of 5T lesions into higher-confidence categories, offering improved diagnostic clarity. Limitations include small sample size and lack of pathologic gold standards.
[68Ga]Ga-P15-041 PET/CT is a promising and accessible bone imaging agent that could complement [68Ga]Ga-PSMA-11 PET/CT in the diagnosis and classification of bone metastases in prostate cancer.
准确诊断前列腺癌骨转移对于分期、预后及治疗至关重要。尽管PSMA PET/CT非常有效，但仍需要补充成像来明确不确定的病变。新型双膦酸盐类药物[68Ga]Ga-P15-041在诊断准确性上优于传统SPECT成像，显示出其作为辅助诊断工具的潜力。本研究探讨其在检测和评估前列腺癌骨转移中的作用。
本前瞻性研究纳入了35例患有前列腺癌和骨转移的患者，他们在1周内接受了[68Ga]Ga-P15-041和[68Ga]Ga-PSMA-11 PET/CT检查。通过[68Ga]Ga-PSMA-11 PET/CT检测到的病变使用前列腺特异性膜抗原报告和数据系统2.0进行分类。
[68Ga]Ga-P15-041 PET/CT检测到的病变比[68Ga]Ga-PSMA-11 PET/CT更多（525个对509个，P < 0.001），并且显示出明显更高的示踪剂摄取，平均SUV为20.73±14.67，而[68Ga]Ga-PSMA-11 PET/CT的平均SUV为11.13±8.12（P < 0.0001）。它检测到的成骨病变明显更多（504个对391个，P < 0.0001）。此外，本研究建立了[68Ga]Ga-P15-041的报告和数据系统（P15-041-RADS），该系统根据SUVmax和形态学变化将前列腺癌骨转移分为5类。P15-041-RADS将85.71%的前列腺特异性膜抗原报告和数据系统3类病变以及95.00%的5T病变重新分类为更高置信度的类别，提高了诊断清晰度。局限性包括样本量小和缺乏病理金标准。
[68Ga]Ga-P15-041 PET/CT是一种有前景且易于获得的骨成像剂，可在前列腺癌骨转移的诊断和分类中补充[68Ga]Ga-PSMA-11 PET/CT。
