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Purpose <p>To investigate the relationship between [<sup>18</sup>F]PSMA-1007 PET parameters and biochemical recurrence-free survival (BCR-FS) in high-risk primary prostate cancer patients receiving neoadjuvant hormonal treatment.</p> Methods <p>This prospective randomized, double-blind, placebo-controlled phase II trial included 89 high-risk primary prostate cancer patients who received a pelvic [<sup>18</sup>F]PSMA-1007 PET/MRI prior to and following neoadjuvant hormonal treatment. Patients were randomly assigned to neoadjuvant hormonal treatment with degarelix + apalutamide (<i>n</i> = 45) or degarelix + matching placebo (<i>n</i> = 44) for 3 months followed by radical prostatectomy and extended pelvic lymph node dissection. The following [<sup>18</sup>F]PSMA-1007 PET parameters were determined on the pre- and posttreatment [<sup>18</sup>F]PSMA-1007 PET: (i) semi-quantitative [<sup>18</sup>F]PSMA-1007 PET parameters such as SUV<sub>max</sub>, SUV<sub>mean</sub>, PSMA-expressing volume and total lesion activity, and their absolute and relative differences; (ii) number of pelvic lymph node, distant and extraprostatic (i.e. pelvic lymph node and distant) metastases determined on [<sup>18</sup>F]PSMA-1007 PET; (iii) [<sup>18</sup>F]PSMA-1007 PET-based response criteria (aPERCIST and RECIP 1.0); (iv) molecular imaging TNM-stage as determined by PROMISE V2.</p> Results <p>35% of included patients developed BCR within a median follow-up time of 38 months. Multivariate regression analyses revealed that PSMA-expressing volume posttreatment, the number of distant metastases pretreatment and miN1 + miN2 vs. miN0 pretreatment were significant predictors of BCR-FS with hazard ratios of 1.184 (95% CI 1.070–1.309, <i>p</i> = 0.0010), 5.820 (95% CI 2.498–13.561, <i>p</i> &lt; 0.0001) and 4.024 (95% CI 1.740–9.307, <i>p</i> = 0.0011), respectively.</p> Conclusion <p>Our results indicate that [<sup>18</sup>F]PSMA-1007 PET might be used to aid in patient stratification for determining which patients would benefit from additional (neo)adjuvant treatment.</p>

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Relationship between [18F]PSMA-1007 PET parameters and biochemical recurrence-free survival in high-risk prostate cancer patients receiving neoadjuvant hormonal treatment

  • 期刊论文

  • 发表日期：

    2025年11月13日

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  • Niloefar Ahmadi Bidakhvidi,
  • Alexander Giesen,
  • Gaëtan Devos,
  • Annouschka Laenen,
  • Marcella Baldewijns,
  • Michel Koole,
  • Christophe M. Deroose,
  • Wouter Everaerts,
  • Steven Joniau,
  • Karolien Goffin

摘要

Purpose

To investigate the relationship between [18F]PSMA-1007 PET parameters and biochemical recurrence-free survival (BCR-FS) in high-risk primary prostate cancer patients receiving neoadjuvant hormonal treatment.

Methods

This prospective randomized, double-blind, placebo-controlled phase II trial included 89 high-risk primary prostate cancer patients who received a pelvic [18F]PSMA-1007 PET/MRI prior to and following neoadjuvant hormonal treatment. Patients were randomly assigned to neoadjuvant hormonal treatment with degarelix + apalutamide (n = 45) or degarelix + matching placebo (n = 44) for 3 months followed by radical prostatectomy and extended pelvic lymph node dissection. The following [18F]PSMA-1007 PET parameters were determined on the pre- and posttreatment [18F]PSMA-1007 PET: (i) semi-quantitative [18F]PSMA-1007 PET parameters such as SUVmax, SUVmean, PSMA-expressing volume and total lesion activity, and their absolute and relative differences; (ii) number of pelvic lymph node, distant and extraprostatic (i.e. pelvic lymph node and distant) metastases determined on [18F]PSMA-1007 PET; (iii) [18F]PSMA-1007 PET-based response criteria (aPERCIST and RECIP 1.0); (iv) molecular imaging TNM-stage as determined by PROMISE V2.

Results

35% of included patients developed BCR within a median follow-up time of 38 months. Multivariate regression analyses revealed that PSMA-expressing volume posttreatment, the number of distant metastases pretreatment and miN1 + miN2 vs. miN0 pretreatment were significant predictors of BCR-FS with hazard ratios of 1.184 (95% CI 1.070–1.309, p = 0.0010), 5.820 (95% CI 2.498–13.561, p < 0.0001) and 4.024 (95% CI 1.740–9.307, p = 0.0011), respectively.

Conclusion

Our results indicate that [18F]PSMA-1007 PET might be used to aid in patient stratification for determining which patients would benefit from additional (neo)adjuvant treatment.