Article Figures & Data
Figures
- FIGURE 1.
Comparison of PET eligibility criteria used in TheraP (inner pie chart) and our retrospective stratification of patients (outer pie chart). In inner pie chart, green fill is patients who fulfilled PET eligibility criteria according to TheraP (TheraP–positive, 72%), gray fill is patients who were excluded because of discordant 18F-FDG–positive, PSMA-negative metastatic disease (18%), and red fill is patients who were not included because of low uptake on 68Ga-PSMA-11 PET/CT (SUVmax-negative, 10%). In outer pie chart (not drawn to scale), green is patients who retrospectively fulfilled inclusion criteria from TheraP (TheraP cePSMA PET–positive, 72%), and red is patients who retrospectively did not fulfill PSMA ligand PET-based SUVmax inclusion criteria (TheraP cePSMA PET–negative, 28%). Asterisk in gap represents patient cohort that was excluded from TheraP on basis of 18F-FDG–positive, PSMA-negative disease and was also not treated with PSMA RLT at our institution because of PSMA-negative visceral or soft-tissue lesions. Hatched areas represent patients in our cohort who were treated with PSMA RLT but might have been excluded from TheraP because of 18F-FDG–positive, PSMA-negative bone disease. ⊕ = positive; ⊖ = negative.
- FIGURE 2.
Examples of 68Ga-PSMA-11 PET/CT in mCRPC patients. (A and B) Maximum-intensity projection (A) and PSMA ligand PET/CT (B, top) and corresponding CT dataset (B, bottom) in 67-y-old patient from TheraP cePSMA PET–negative group with bone and lymph node metastases presenting with retrocrural lymph node metastasis with short-axis diameter of 14 mm and SUVmax of 8.1 (arrows). (C and D) Maximum-intensity projection (C) and PSMA ligand PET/CT (D, top) with corresponding CT dataset (D, bottom) in 74-y-old patient from TheraP cePSMA PET–positive group with bone and lymph node metastases presenting with retrocrural lymph node metastasis with short-axis diameter of 11 mm and SUVmax of 10.8 (arrows). PSA PFS and OS were 11 wk and 8 mo, respectively, in patient shown in A and B and 45 wk and 45 mo, respectively, in patient shown in C and D.
- FIGURE 3.
Waterfall plot showing response to treatment as measured by serum PSA. Color-coded best PSA response is defined as smallest increase or greatest decrease in PSA from baseline. Green indicates patients who fulfilled PET eligibility criteria (TheraP cePSMA PET–positive, n = 77). Red indicates patients who did not fulfill TheraP PET-based inclusion criteria (TheraP cePSMA PET–negative, n = 30). Asterisks indicate patients with increase of more than 100% in best PSA response.
- FIGURE 4.
Kaplan–Meier survival curves for PSA PFS (A) and OS (B) in TheraP cePSMA PET–positive and TheraP cePSMA PET–negative patients.
- FIGURE 5.
Kaplan–Meier survival curves for PSA PFS and OS in exploratory cePSMA PET–positive and exploratory cePSMA PET–negative patients stratified according to presence of PSMA-positive disease with SUVmax of at least 10 and 15 (A), 25 (B), 30 (C), 35 (D), 40 (E), and 45 and 50 (E).
Tables
Characteristic Data No. of patients 107 Age (y) 73 (66–76) PSA (ng/mL) 115 (19–324) Lactate dehydrogenase (U/L) 266 (217–350) Alkaline phosphatase (U/L) 101 (72–229) Hemoglobin (g/dL) 11.5 (10.1–12.4) Prior systemic therapies for mCRPC Docetaxel 82 Cabazitaxel 20 Abiraterone 87 Enzalutamide 63 223Ra 19 Previous chemotherapy 82 Site of metastasis Lymph node, overall 87 Lymph node only (N1+/M1a) 7 Bone overall 97 Bone (M1b, without visceral metastases) 71 Visceral, overall (M1c) 31 Liver 10 Lung 14 Adrenal 10 Qualitative data are number and percentage; continuous data are median and interquartile range (n = 107).
Criterion PET-based eligibility in TheraP using 68Ga-PSMA-11 and 18F-FDG PET (7) Institutional PET-based eligibility criteria using 68Ga-PSMA-11 and contrast-enhanced CT Inclusion PSMA-positive disease with at least SUVmax of 20 at site of disease; SUVmax greater than 10 at all other sites of measurable (diameter, ≥10 mm) metastatic disease PSMA ligand uptake at least as high as liver background uptake in most metastatic lesions Exclusion Metastatic site of disease with discordant 18F-FDG–positive and 68Ga-PSMA-11–negative findings Any negative visceral metastases (>1 cm) or relevant fraction (∼>25%) of soft-tissue lesions in contrast-enhanced CT with PSMA ligand uptake lower than liver uptake Univariate analysis Multivariate analysis Parameter Patients (n) HR 95% CI P HR 95% CI P TheraP criteria 107 TheraP cePSMA PET–negative 30 Reference TheraP cePSMA PET–positive 77 0.5 0.3–0.8 0.001* 0.5 0.3–0.8 0.003* Visceral metastases 107 No Reference Yes 1.7 1.2–2.6 0.02* 2.2 1.3–.2.7 0.005* Lymph node only 107 No Reference Yes 0.4 0.2–1.1 0.07 0.6 0.2–1.6 0.3 Previous abiraterone 107 No Reference Yes 1.1 0.7–1.9 0.7 1.5 0.9–2.7 0.2 Previous enzalutamide 107 No Reference Yes 0.9 0.6–1.4 0.7 0.7 0.5–1.1 0.2 Previous 223Ra 107 No Reference Yes 0.9 0.5–1.5 0.7 0.7 0.4–1.2 0.2 Previous chemotherapy 107 Yes Reference No 0.7 0.5–1.2 0.2 1.3 0.7–2.5 0.3 Age, risk change with 10 y increase 107 Continuous 1.0 0.8–1.4 0.9 1.1 0.8–1.5 0.7 PSA, risk change with 50 ng/mL increase 107 Continuous 1.0 1.0–1.0 0.02* 1.0 1.0–1.0 0.5 Hemoglobin (g/dL) 107 Continuous 0.8 0.7–0.8 <0.0001* 0.7 0.6–0.9 <0.001* AP, risk change with 50 U/L increase 107 Continuous 1.0 1.0–1.0 0.05 1.0 1.0–1.1 0.9 LDH, risk change with 50 U/L increase 107 Continuous 1.0 1.0–1.1 <0.0001* 1.1 1.0–1.1 0.03* ↵* Statistically significant.
AP = alkaline phosphatase; LDH = lactate dehydrogenase.
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