Scholarlink

Purpose <p>This prospective imaging trial was designed to compare [<sup>68</sup>Ga]PSMA-11 PET/CT with multiparametric MRI (mpMRI) in parallel in men with suspicion of prostate cancer (PCa) after at least one previous negative biopsy (ClinicalTrials.gov: NCT05297162; GR-2018-12366240).</p> Materials and methods <p>Between April 2022 and June 2025, we enrolled 130 patients who met the inclusion criteria and completed protocol investigations. Target lesions were defined based on PI-RADS v2.1 for mpMRI and PRIMARY Score, SUVmax and SUVratio for [<sup>68</sup>Ga]PSMA-11 PET/CT. Findings were statistically correlated with pathology results. Subsequently, we developed a nomogram to predict clinically significant PCa (csPCa), defined as International Society of Urological Pathology [ISUP] grade ≥ 2, using Boruta’s algorithm for variable selection.</p> Results <p>Median age in our cohort was 65.5 years (range, 50.5–82.2) and median PSA 9.7 ng/ml (range, 4–35). According to pathology, 20 patients (15.4%) had csPCa, while most had negative biopsies (95;73%). Median SUVmax and SUVratio were 3.9 (range, 1.9–49.9) and 1.5 (range, 1-17.3), respectively, with optimal cut-offs of SUVmax &gt; 6 and SUVratio ≥ 2.8. Diagnostic accuracy for csPCa was significantly higher for PRIMARY score than for PI-RADS (92% vs. 83%; <i>p</i> = 0.0344). Clinical and imaging variables were significantly correlated with csPCa (<i>p</i> &lt; 0.01), with PSA density, PRIMARY score, SUVratio, and PI-RADS emerging as independent predictors. Based on these findings, we developed the PRIMER (<Emphasis Type="BoldUnderline">P</Emphasis>SA density, <Emphasis Type="BoldUnderline">R</Emphasis>adiological <Emphasis Type="BoldUnderline">I</Emphasis>ndex, <Emphasis Type="BoldUnderline">M</Emphasis>etabolic <Emphasis Type="BoldUnderline">E</Emphasis>valuation, <Emphasis Type="BoldUnderline">R</Emphasis>e-biopsy setting) nomogram to assess csPCa likelihood, achieving an AUC of 0.8957 in the training set.</p> Conclusions <p>[<sup>68</sup>Ga]PSMA-11 PET/CT outperformers mpMRI in the re-biopsy setting. The developed PRIMER nomogram can predict csPCa likelihood before biopsy.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

[68Ga]PSMA-11 PET/CT vs. mpMRI in patients with a high suspicion of prostate cancer and previous negative biopsy: head to head, parallel, prospective trial (PROSPET-BX)

  • 期刊论文

  • 发表日期：

    2026年3月5日

查看全文
  • Egesta Lopci,
  • Massimo Lazzeri,
  • Alberto Saita,
  • Cesare Saitta,
  • Luca Disconzi,
  • Piergiuseppe Colombo,
  • Vittorio Fasulo,
  • Gianluca Tarullo,
  • Elisa Vuono,
  • Roberto Peschechera,
  • Roberta Zanca,
  • Jelena Jandric,
  • Federica Mrakic Sposta,
  • Emanuele Scapaticci,
  • Marco Paciotti,
  • Rodolfo Hurle,
  • Alessio Benetti,
  • Pier Paolo Avolio,
  • Miriam Cieri,
  • Silvia Zandegiacomo,
  • Luisa Pasini,
  • Paolo Casale,
  • Giorgio Guazzoni,
  • Luca Balzarini,
  • Andrea Laghi,
  • Nicolò Maria Buffi,
  • Giovanni Lughezzani

摘要

Purpose

This prospective imaging trial was designed to compare [68Ga]PSMA-11 PET/CT with multiparametric MRI (mpMRI) in parallel in men with suspicion of prostate cancer (PCa) after at least one previous negative biopsy (ClinicalTrials.gov: NCT05297162; GR-2018-12366240).

Materials and methods

Between April 2022 and June 2025, we enrolled 130 patients who met the inclusion criteria and completed protocol investigations. Target lesions were defined based on PI-RADS v2.1 for mpMRI and PRIMARY Score, SUVmax and SUVratio for [68Ga]PSMA-11 PET/CT. Findings were statistically correlated with pathology results. Subsequently, we developed a nomogram to predict clinically significant PCa (csPCa), defined as International Society of Urological Pathology [ISUP] grade ≥ 2, using Boruta’s algorithm for variable selection.

Results

Median age in our cohort was 65.5 years (range, 50.5–82.2) and median PSA 9.7 ng/ml (range, 4–35). According to pathology, 20 patients (15.4%) had csPCa, while most had negative biopsies (95;73%). Median SUVmax and SUVratio were 3.9 (range, 1.9–49.9) and 1.5 (range, 1-17.3), respectively, with optimal cut-offs of SUVmax > 6 and SUVratio ≥ 2.8. Diagnostic accuracy for csPCa was significantly higher for PRIMARY score than for PI-RADS (92% vs. 83%; p = 0.0344). Clinical and imaging variables were significantly correlated with csPCa (p < 0.01), with PSA density, PRIMARY score, SUVratio, and PI-RADS emerging as independent predictors. Based on these findings, we developed the PRIMER (PSA density, Radiological Index, Metabolic Evaluation, Re-biopsy setting) nomogram to assess csPCa likelihood, achieving an AUC of 0.8957 in the training set.

Conclusions

[68Ga]PSMA-11 PET/CT outperformers mpMRI in the re-biopsy setting. The developed PRIMER nomogram can predict csPCa likelihood before biopsy.