Research ArticleClinical Investigation

The Diagnostic Value of PSMA PET/CT in Men with Newly Diagnosed Unfavorable Intermediate-Risk Prostate Cancer

Marinus J. Hagens, Wietske I. Luining, Auke Jager, Maarten L. Donswijk, Zing Cheung, Maurits Wondergem, Daniela E. Oprea-Lager, André N. Vis, Pim J. van Leeuwen and Henk G. van der Poel
Journal of Nuclear Medicine August 2023, 64 (8) 1238-1243; DOI: https://doi.org/10.2967/jnumed.122.265205

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Tables

  • TABLE 1.

    American Urological Association Risk Groups for Localized PCa

    Risk groupDescription
    Low riskPSA < 10 ng/mL and Gleason score < 7 (ISUP GG1) and cT1–2a
    Intermediate risk
     FavorablePSA 10–20 ng/mL or Gleason score 7 (ISUP GG2) or cT2b–c
     UnfavorablePSA 10–20 ng/mL or Gleason score 7 (ISUP GG3) or cT2b–c
    High riskPSA > 20 ng/mL or Gleason score > 7 (ISUP GG4–5) or cT3–4

    • cT stage = clinical tumor stage.

  • TABLE 2.

    Patient Characteristics of Both Entire Study Population and Subgroups With and Without PSMA-Expressing Metastases

    CharacteristicOverall (n = 396)Patients without metastases (n = 359)Patients with metastases (n = 37)P
    Age (y)69 (63–73)68 (63–73)70 (66–75)0.16
    Clinical tumor stage0.30
     cT1c162 (40.9%)150 (41.8%)12 (32.4%)
     cT2234 (59.1%)209 (58.2%)25 (67.6%)
    PSA (ng/mL)8.5 (6.2–11.3)8.3 (5.9–11.0)10.0 (7.3–14.8)0.001
    Prostate volume (mL)41 (31–53)40 (31–52)47 (31–63)0.13
    PSA density (ng/mL/cm3)0.20 (0.13–0.30)0.19 (0.13–0.29)0.22 (0.13–0.35)0.16
    Prebiopsy MRI381 (96.2%)349 (97.2%)32 (86.5%)0.01
    PI-RADS category0.54
     ≤212 (3.1%)12 (3.4%)—
     322 (5.6%)21 (5.8%)1 (2.7%)
     4154 (38.9%)143 (39.8%)11 (29.7%)
     5186 (47.0%)166 (46.2%)20 (54.1%)
     Missing22 (5.6%)17 (4.7%)5 (13.5%)
    Radiologic tumor stage0.001
     rT1c12 (3.0%)12 (3.3%)—
     rT2267 (67.4%)252 (70.2%)16 (42.1%)
     rT3a73 (18.4%)61 (17.0%)12 (32.4%)
     rT3b27 (6.8%)22 (6.1%)5 (13.5%)
     Missing17 (4.3%)12 (3.3%)5 (13.5%)
    Biopsy approach0.93
     SBx168 (42.4%)151 (42.1%)17 (45.9%)
     TBx27 (6.8%)25 (7.0%)2 (5.4%)
     SBx+TBx199 (50.3%)181 (50.4%)18 (48.6%)
     Missing2 (0.5%)2 (0.6%)—
    Type of core ISUP GG3 was found in…0.47
     TBx123 (31.1%)114 (31.9%)9 (24.3%)
     SBx200 (50.5%)181 (50.7%)19 (51.4%)
     TBx and SBx71 (17.9%)62 (17.4%)9 (24.3%)
     Missing2 (0.5%)2 (0.6%)—
    Percentage of positive biopsies41.7 (23.1–62.5)40.0 (22.2–59.2)70.0 (40.7–88.1)<0.001
    Percentage of ISUP GG3 in biopsies26.7 (14.3–44.4)25.0 (13.8–43.7)40.8 (28.0–74.1)0.001
    Cribriform growth220 (55.6%)194 (54.3%)25 (65.8%)0.16

    • Radiologic tumor stage refers to tumor stage indicated on MRI. Prostate volume was manually assessed on MRI following suggested measurements for ellipsoid formula in PI-RADS, version 2.1. Continuous variables are shown as median with IQR, and categoric variables are shown as numbers and percentages.

  • TABLE 3.

    PSMA PET/CT Results for All Unfavorable Intermediate-Risk PCa Patients by Applied PSMA Radiotracer

    ResultOverall (n = 396)[18F]DCFPyL (n = 182)[18F]PSMA-JK7 (n = 45)[18F]PSMA-1007 (n = 24)[68Ga]PSMA-11 (n = 145)P
    Positive scan378 (95.5%)174 (95.6%)42 (93.3%)24 (100.0%)138 (95.2)0.65
    Metastatic disease37 (9.3%)10 (5.5%)4 (8.9%)6 (25.0%)17 (11.7)0.01
    miN129 (7.3%)9 (4.9%)4 (8.9%)3 (12.5%)13 (9.0%)0.36
    miM1a3 (0.8%)2 (1.1%)——1 (0.7%)0.41
    miM1b14 (3.5%)5 (2.7%)—5 (20.8%)4 (2.8%)0.02
  • TABLE 4.

    Detection of PSMA-Expressing Locoregional Lymph Node or Distant Metastases on PET/CT Multivariate Logistic Regression Analysis

    ResultOdds ratioP
    Positive needle biopsy cores (%)—
     ≤50Reference
     >503.87 (95% CI, 1.74–8.62)0.001
    Radiologic tumor stage—
     rT1–2Reference
     rT32.72 (95% CI, 1.27–5.83)0.01

    • Univariate significant variables added to analysis: PSA level (P = 0.001), radiologic tumor stage on MRI (P = 0.001), percentage of positive prostate biopsies (P < 0.001), and percentage of ISUP GG3 in prostate biopsies (P = 0.001). Percentage of positive prostate biopsies (≤50% and >50%) and percentage of ISUP GG3 in prostate biopsies (≤50% and >50%) were included as ordinal variables for clinical relevance.

  • TABLE 5.

    Incidence of Metastatic Disease and NNI According to Prostate Cancer Network Netherlands Subclassification

    ResultLow metastatic potential: rT1–2 and ≤50% positive prostate biopsiesModerate metastatic potential: rT1–2 and >50% and ≤75% positive prostate biopsiesHigh metastatic potential: rT3–4 or >75% positive prostate biopsies
    Metastatic disease6/197 (3.0%)5/53 (9.4%)24/130 (18.5%)
    miN14/6 (66.7%)4/5* (80.0%)20/24* (83.3%)
    miM1a——3/24* (12.5%)
    miM1b2/6 (33.3%)2/5* (20.0%)8/24* (33.3%)
    NNI32105

    • ↵* Patients could have multiple metastatic lesions simultaneously.

    • rT = radiologic tumor stage.

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