TABLE 1

Baseline Characteristics at Time of First 177Lu-PRLT and Gleason Score/Disease Stage at Initial Diagnosis

CharacteristicT-pretreated (n = 83)T-naïve (n = 84)P
Age (y)69.3 ± 8.770.8 ± 7.80.249
Karnofsky performance status0.003
 <7016 (19%)6 (7%)
 7013 (16%)7 (8%)
 8024 (29%)24 (29%)
 9028 (34%)33 (39%)
 1002 (2%)14 (17%)
Metastatic disease extent
 Bone metastases75 (90%)66 (79%)0.036
 Nodal metastases68 (82%)68 (81%)0.871
 Visceral metastases (liver or lung)20 (24%)16 (19%)0.428
Additional prior therapy
 Abiraterone or enzalutamide63 (76%)32 (38%)<0.001
 Nontaxane chemotherapy9 (11%)0 (0%)NA
223Ra12 (14%)2 (2%)0.005
 External beam radiotherapy to bone30 (36%)25 (30%)0.380
Time between initial diagnosis and first 177Lu-PRLT (mo)68.8 (34.3–125.7)72.3 (32.5–132.8)0.813
PSA (ng/mL)196.3 (34.1–766.1)33.6 (4.9–106.4)<0.001
Hematologic results
 Hemoglobin (mmol/L)6.9 (5.9–7.9)8.0 (7.2–8.5)<0.001
 Red blood cell count (10 ^ 6/μL)4.0 (3.5–4.3)4.2 (3.9–4.5)0.002
 White blood cell count (10 ^ 3/μL)6.6 (5.0–8.1)6.2 (5.0–7.2)0.129
 Platelet count (10 ^ 3/μL)207 (181–265)216 (173–259)0.794
Renal function tests*
 Creatinine (μmol/L)77.5 (67.8–92.0)77.7 (68.2–92.6)0.753
 Urea (mmol/L)7.0 (5.4–8.5)6.3 (5.3–7.4)0.048
 eGFR (mL/min)86.1 (70.5–100.6)86.2 (70.0–97.8)0.848
Liver function tests*
 Bilirubin (μmol/L)5 (4–7)6 (5–8)0.016
 AST (U/L)26 (20–50)23 (19–31)0.044
 ALT (U/L)16 (12–24)17 (12–24)0.600
 GGT (U/L)32 (22–80)22 (17–48)0.004
 ALP (U/L)128 (69–282)84 (60–150)0.007
Gleason score at initial diagnosis0.062
 ≤719 (23%)33 (39%)
 ≥846 (55%)41 (49%)
 Unknown18 (22%)10 (12%)
Disease stage at initial diagnosis
 T stage0.165
  T1/211 (13%)18 (21%)
  T3/449 (59%)44 (52%)
  TX23 (28%)22 (26%)
 N stage0.540
  N030 (36%)32 (38%)
  N125 (30%)21 (25%)
  NX28 (34%)31 (37%)
 M stage0.698
  M035 (42%)30 (36%)
  M118 (22%)13 (15%)
  MX30 (36%)41 (49%)
  • * Data available for 83 patients in the T-naïve group.

  • Data available for 82 patients in the T-pretreated group.

  • NA = not applicable; eGFR = estimated glomerular filtration rate; AST = aspartate aminotransferase; ALT = alanine aminotransferase; GGT = γ-glutamyl transferase.