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Research ArticleClinical Investigation

Prognostic Performance of RECIP 1.0 Based on [18F]PSMA-1007 PET in Prostate Cancer Patients Treated with [177Lu]Lu-PSMA I&T

Philipp E. Hartrampf, Thomas Hüttmann, Anna Katharina Seitz, Hubert Kübler, Sebastian E. Serfling, Takahiro Higuchi, Wiebke Schlötelburg, Kerstin Michalski, Andrei Gafita, Steven P. Rowe, Martin G. Pomper, Andreas K. Buck and Rudolf A. Werner
Journal of Nuclear Medicine April 2024, 65 (4) 560-565; DOI: https://doi.org/10.2967/jnumed.123.266702
Philipp E. Hartrampf
1Department of Nuclear Medicine, University Hospital Würzburg, Würzburg, Germany;
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Thomas Hüttmann
1Department of Nuclear Medicine, University Hospital Würzburg, Würzburg, Germany;
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Anna Katharina Seitz
2Department of Urology and Pediatric Urology, University Hospital Würzburg, Würzburg, Germany;
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Hubert Kübler
2Department of Urology and Pediatric Urology, University Hospital Würzburg, Würzburg, Germany;
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Sebastian E. Serfling
1Department of Nuclear Medicine, University Hospital Würzburg, Würzburg, Germany;
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Takahiro Higuchi
1Department of Nuclear Medicine, University Hospital Würzburg, Würzburg, Germany;
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Wiebke Schlötelburg
1Department of Nuclear Medicine, University Hospital Würzburg, Würzburg, Germany;
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Kerstin Michalski
1Department of Nuclear Medicine, University Hospital Würzburg, Würzburg, Germany;
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Andrei Gafita
3Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins School of Medicine, Baltimore, Maryland;
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Steven P. Rowe
4Division of Molecular Imaging and Therapeutics, Department of Radiology, University of North Carolina, Chapel Hill, North Carolina; and
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Martin G. Pomper
3Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins School of Medicine, Baltimore, Maryland;
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Andreas K. Buck
1Department of Nuclear Medicine, University Hospital Würzburg, Würzburg, Germany;
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Rudolf A. Werner
1Department of Nuclear Medicine, University Hospital Würzburg, Würzburg, Germany;
3Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins School of Medicine, Baltimore, Maryland;
5Division of Nuclear Medicine, Department of Diagnostic and Interventional Radiology and Nuclear Medicine, University Hospital, Goethe University Frankfurt, Frankfurt, Germany
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    FIGURE 1.

    Kaplan–Meier analyses of patients grouped according to RECIP 1.0, PCWG3 PSA, and combined assessment for PD or non-PD. Patients with PD according to RECIP 1.0 (OS, 9 mo vs. 17 mo) (A), PCWG3 PSA (OS, 9 mo vs. 19 mo) (B), and combined PD (OS, 8 mo vs. 19 mo) (C) showed shorter OS. However, only segregations based on PCWG3 and PCWG3 with RECIP 1.0 reached significance.

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    TABLE 1.

    RECIP 1.0 Classification (8,30) and Modified PSA Response According to PCWG3 (5)

    Disease stageDescription
    RECIP 1.0*
     PD>20% increase of tumor volume with appearance of new lesions
     StD<30% decrease in tumor volume with or without appearance of new lesions, or ≥30% decrease in tumor volume with appearance of new lesions, or <20% increase in tumor volume with or without appearance of new lesions, or ≥20% increase in tumor volume without appearance of new lesions
     Partial response>30% decrease in tumor volume without appearance of new lesions
     Complete responseAbsence of any PSMA uptake on follow-up PET scan
    PCWG3
     PD≥25% increase in PSA levels at interim PET
     Response≥50% decrease in PSA levels at interim PET
    • ↵* New lesions were defined as tumor uptake of PSMA ligand higher than that of surrounding background, with SUVmax higher than blood-pool SUVmax, which was not present at baseline PET.

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    TABLE 2.

    Patient Characteristics

    ParameterData
    Clinical variables
     Age at first cycle of PSMA RLT (y)72 (46–88)
     IntervalDiagnosis-RLT (mo)77 (9–274)
     Treatment cycles per patient4 (2–8)
     Cumulative activity (GBq)19.1 (11.2–50.9)
     Gleason score9 (6–10)
    Baseline laboratory values
     PSA (ng/mL)107.0 (2.9–3,590)
     CRP (mg/dL)0.42 (0.1–12.7)
     LDH (U/L)245.0 (152–593)
     Hemoglobin (g/dL)12.0 (7.7–14.8)
     AP (U/L)127.0 (39.0–3,330)
     PSMA-TV (cm3)730.7 (5.0–3,301)
     TL-PSMA (cm3)5135 (20.2–33,441)
     SUVmax39.7 (6.6–190.9)
     SUVpeak19.3 (4.3–94.1)
     SUVmean7.6 (4.0–16.3)
    Sites of metastases (n) (total n = 73)
     Bone72 (98.6%)
     Lymph node49 (67.1%)
     Visceral28 (38.4%)
     Liver16 (21.9%)
     Lung11 (15.1%)
    Prior treatments (%)
     Radical prostatectomy41.1
     Primary radiation therapy to prostate13.7
     Antihormonal treatment100
     Enzalutamide79.5
     Abiraterone68.5
     Chemotherapy79.5
     223Ra2.7
    • IntervalDiagnosis-RLT = time between initial diagnosis and first RLT; CRP = C-reactive protein; LDH = lactate dehydrogenase; AP = alkaline phosphatase.

    • Continuous data are median and range

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    TABLE 3.

    Change After 2 Cycles of RLT

    VariablesDataReduction
    Change in PSMA-TV (cm3)+27.2 (−66.9–8,934)30 (41.1%)
     Bone+28.1 (−71.4–1,699)
     Lymph node−21.8 (−100–5,835)
    Change in TL-PSMA (cm3)−0.8 (−86.6–5,627)37 (50.7%)
    Change in SUVmax−30.1 (−83.7–43.7)61 (83.6%)
    Change in SUVpeak−31.6 (−86.7–60.3)58 (79.5%)
    Change in SUVmean−25.5 (−71.3–38.1)62 (84.9%)
    Change in PSA+1.9 (−99.1–870)36 (49.3%)
    • Continuous data are median and range. Quantitative data are number of patients and percentage.

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    TABLE 4.

    Univariable and Multivariable Cox Regression

    ParameterUnivariableMultivariable
    HR95% CIC-indexPHR95% CIP
    Change in PSMA-TV (%)1.0031.000–1.0050.680.031.0010.9972–1.0040.62
    Change in TL-PSMA (%)1.0021.000–1.0040.650.13
    Change in SUVmean (%)1.0000.9800–1.0180.510.90
    Change in SUVpeak (%)1.0050.9945–1.0150.540.34
    Change in SUVmax (%)1.0050.9923–1.0170.540.46
    Change in PSA (%)1.0041.002–1.0070.690.0011.0041.000–1.0060.03
    New metastases1.9020.8780–4.2490.600.101.0230.4469–2.5360.96
    RECIP 1.0 PD*2.1000.9611–4.5900.600.06
    PCWG3 PD*2.2881.018–5.1000.630.04
    RECIP+PCWG3 PD*3.2971.493–7.7910.690.004
    Any PSA response0.50260.2278–1.0920.610.08
    PSA response >50%0.43390.1720–0.97280.630.05
    • ↵* Tested vs. all non-PD patients in entire cohort.

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Journal of Nuclear Medicine: 65 (4)
Journal of Nuclear Medicine
Vol. 65, Issue 4
April 1, 2024
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Prognostic Performance of RECIP 1.0 Based on [18F]PSMA-1007 PET in Prostate Cancer Patients Treated with [177Lu]Lu-PSMA I&T
Philipp E. Hartrampf, Thomas Hüttmann, Anna Katharina Seitz, Hubert Kübler, Sebastian E. Serfling, Takahiro Higuchi, Wiebke Schlötelburg, Kerstin Michalski, Andrei Gafita, Steven P. Rowe, Martin G. Pomper, Andreas K. Buck, Rudolf A. Werner
Journal of Nuclear Medicine Apr 2024, 65 (4) 560-565; DOI: 10.2967/jnumed.123.266702

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Prognostic Performance of RECIP 1.0 Based on [18F]PSMA-1007 PET in Prostate Cancer Patients Treated with [177Lu]Lu-PSMA I&T
Philipp E. Hartrampf, Thomas Hüttmann, Anna Katharina Seitz, Hubert Kübler, Sebastian E. Serfling, Takahiro Higuchi, Wiebke Schlötelburg, Kerstin Michalski, Andrei Gafita, Steven P. Rowe, Martin G. Pomper, Andreas K. Buck, Rudolf A. Werner
Journal of Nuclear Medicine Apr 2024, 65 (4) 560-565; DOI: 10.2967/jnumed.123.266702
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Keywords

  • PSMA
  • RECIP
  • PET/CT
  • [18F]PSMA-1007
  • [177Lu]Lu-PSMA I&T
  • PCWG3
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