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Purpose <p>This prospective, multicentre, intra-patient comparator study assessed urinary radioactivity, and patient-level and region-level detection rates (DR) with PSMA-PET radiopharmaceuticals, <sup>18</sup>F-piflufolastat (<sup>18</sup>F-DCFPyL) and <sup>18</sup>F-flotufolastat (<sup>18</sup>F-rhPSMA-7.3) in patients with biochemical recurrence (BCR) of prostate cancer to evaluate the hypothesis that lower urinary radioactivity is observed with <sup>18</sup>F-flotufolastat.</p> Methods <p>Patients with low PSA (≤0.5&#xa0;ng/mL) BCR ≥6&#xa0;months post-prostatectomy with undetectable PSA post-surgery, scheduled for standard-of-care <sup>18</sup>F-piflufolastat PSMA-PET were enrolled. Patients underwent PET/CT 60&#xa0;minutes post-<sup>18</sup>F-piflufolastat (9&#xa0;mCi) administration, and a second PET/CT on the same scanner 1–10&#xa0;days later, 60&#xa0;minutes post-<sup>18</sup>F-flotufolastat (8&#xa0;mCi) administration. The primary endpoint was the difference in urinary radioactivity (SUV<sub>mean</sub>) between the radiopharmaceuticals. Secondary endpoints included patient-level and region-level DR for each radiopharmaceutical, assessed by two blinded readers (a third resolved disagreements, allowing majority reads).</p> Results <p>Fifty-five evaluable patients (mean PSA, 0.28&#xa0;ng/mL) were enrolled. Median bladder SUV<sub>mean</sub> was significantly higher with <sup>18</sup>F-piflufolastat (29.0; interquartile range, 18.9–40.8) than <sup>18</sup>F-flotufolastat (10.9; interquartile range, 6.0–18.5; <i>p</i> &lt; 0.001 [Wilcoxon signed-rank test]). Majority read patient-level DR were 27.3% (15/55) for <sup>18</sup>F-piflufolastat and 45.5% (25/55) for <sup>18</sup>F-flotufolastat. Region-level DR for <sup>18</sup>F-piflufolastat and <sup>18</sup>F-flotufolastat, were 10.9% (6/55) and 18.2% (10/55) in the prostate bed, 14.5% (8/55) and 16.4% (9/55) in pelvic lymph nodes, and 7.3% (4/55) and 21.8% (12/55) in extra-pelvic sites. Among patients with PSA ≤0.2&#xa0;ng/mL, 38.1% (8/21) and 52.4% (11/21) had positive <sup>18</sup>F-piflufolastat and <sup>18</sup>F-flotufolastat scans, respectively.</p> Conclusions <p>This intra-patient comparator shows <sup>18</sup>F-flotufolastat has significantly lower urinary radioactivity than <sup>18</sup>F-piflufolastat, which may help to optimise image assessment in regions close to the urinary tract.</p> Clinical trial registration <p>Trial registration, clinicaltrials.gov: NCT06604442. Registered September 2024.</p>

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An intra-patient contemporaneous comparison of 18F-piflufolastat and 18F-flotufolastat urinary radioactivity and pelvic region detection rates in men with low PSA biochemical recurrence of prostate cancer after radical prostatectomy

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  • 发表日期：

    2026年2月23日

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  • Luke T. Nordquist,
  • Jack R. Andrews,
  • Phillip H. Kuo,
  • Benjamin A. Gartrell,
  • David Josephson,
  • Andrei S. Purysko,
  • Daniel R. Saltzstein,
  • Ram A. Pathak,
  • Neal Shore,
  • James Sykes,
  • Ross Penny,
  • Phillip Davis,
  • Brian T. Helfand

摘要

Purpose

This prospective, multicentre, intra-patient comparator study assessed urinary radioactivity, and patient-level and region-level detection rates (DR) with PSMA-PET radiopharmaceuticals, 18F-piflufolastat (18F-DCFPyL) and 18F-flotufolastat (18F-rhPSMA-7.3) in patients with biochemical recurrence (BCR) of prostate cancer to evaluate the hypothesis that lower urinary radioactivity is observed with 18F-flotufolastat.

Methods

Patients with low PSA (≤0.5 ng/mL) BCR ≥6 months post-prostatectomy with undetectable PSA post-surgery, scheduled for standard-of-care 18F-piflufolastat PSMA-PET were enrolled. Patients underwent PET/CT 60 minutes post-18F-piflufolastat (9 mCi) administration, and a second PET/CT on the same scanner 1–10 days later, 60 minutes post-18F-flotufolastat (8 mCi) administration. The primary endpoint was the difference in urinary radioactivity (SUVmean) between the radiopharmaceuticals. Secondary endpoints included patient-level and region-level DR for each radiopharmaceutical, assessed by two blinded readers (a third resolved disagreements, allowing majority reads).

Results

Fifty-five evaluable patients (mean PSA, 0.28 ng/mL) were enrolled. Median bladder SUVmean was significantly higher with 18F-piflufolastat (29.0; interquartile range, 18.9–40.8) than 18F-flotufolastat (10.9; interquartile range, 6.0–18.5; p < 0.001 [Wilcoxon signed-rank test]). Majority read patient-level DR were 27.3% (15/55) for 18F-piflufolastat and 45.5% (25/55) for 18F-flotufolastat. Region-level DR for 18F-piflufolastat and 18F-flotufolastat, were 10.9% (6/55) and 18.2% (10/55) in the prostate bed, 14.5% (8/55) and 16.4% (9/55) in pelvic lymph nodes, and 7.3% (4/55) and 21.8% (12/55) in extra-pelvic sites. Among patients with PSA ≤0.2 ng/mL, 38.1% (8/21) and 52.4% (11/21) had positive 18F-piflufolastat and 18F-flotufolastat scans, respectively.

Conclusions

This intra-patient comparator shows 18F-flotufolastat has significantly lower urinary radioactivity than 18F-piflufolastat, which may help to optimise image assessment in regions close to the urinary tract.

Clinical trial registration

Trial registration, clinicaltrials.gov: NCT06604442. Registered September 2024.