Article Figures & Data
Figures
- FIGURE 1.
Patient disposition. aPSMA-PROSTATA registry enrollment criteria: patients enrolled in the trial were men with proven diagnosis of PC, who had received radical prostatectomy or radiotherapy as definitive therapy, who had proven biochemical recurrence (defined as 2 consecutive PSA assays ≥ 0.2 ng/mL), who had PSA levels between 0.2 and 2.0 ng/mL, were aged ≥ 35 y, and who had provided written informed consent. Patients were excluded if they were unable to lie flat, to be still, or to tolerate PET/CT scanning or had a history of treatment for another cancer within 1 y before [68Ga]Ga-PSMA-11 PET/CT. Use of concomitant therapies, including ADT, were allowed. Follow-up data from routine clinical, pathologic, PET/CT imaging, and PSA levels were collected from patient records. bPatients eligible for study inclusion had proven diagnosis of CRPC as defined by the European Association of Urology guidelines as: serum testosterone < 50 ng/dL or 1.7 nmol/L plus either biochemical progression (rising serum PSA levels) or radiologic progression (appearance of new lesions). cLife-prolonging therapy included novel hormone therapy (abiraterone, enzalutamide), taxanes (docetaxel, cabazitaxel), [223Ra]Ra-NaCl, and PSMA-RLT. CRPC = castration-resistant prostate cancer; mCRPC = metastatic castration-resistant prostate cancer; PC = prostate cancer; PET/CT = positron emission tomography/computed tomography; PSA = prostate-specific antigen; PSMA = prostate-specific membrane antigen; PSMA-RLT = α-/β-emitter prostate-specific membrane antigen-radioligand therapy.
- FIGURE 2.
Association of PFS after second PET/CT with PET/CT response (A), change from baseline in serum PSA level (B), and combination of PET/CT response and change from baseline in serum PSA level (C) (n = 63). mo = months; PET/CT = positron emission tomography/computed tomography; PFS = progression-free survival; PSA = prostate-specific antigen.
- FIGURE 3.
Association of OS with PET/CT response (A) and change from baseline in serum PSA level (B) (n = 63). mo = months; OS = overall survival; PET/CT = positron emission tomography/computed tomography; PSA = prostate-specific antigen.
Tables
Characteristic Overall (N = 160) mCRPC (n = 152) nmCRPC (n = 8) Before PET/CT Median age (y) 72 (IQR, 67–77) 72 (IQR, 67–76) 77 (IQR, 73–78) Gleason score (n) 5 3 (1.9%) 3 (2.0%) 0 6 3 (1.9%) 3 (2.0%) 0 7 58 (36.3%) 56 (36.8%) 2 (25.0%) 8 40 (25.0%) 37 (24.3%) 3 (37.5%) 9 53 (33.1%) 50 (32.9%) 3 (37.5%) 10 3 (1.9%) 3 (2.0%) 0 TNM classification (n) T2 27 (16.9%) 25 (16.4%) 2 (25.0%) T3 92 (57.5%) 87 (57.2%) 5 (62.5%) T4 5 (3.1%) 5 (3.3%) 0 Missing 36 (22.5%) 35 (23.0%) 1 (12.5%) N1 41 (25.6%) 40 (26.3%) 1 (12.5%) M1 34 (21.3%) 33 (21.7%) 1 (12.5%) R1 43 (26.9%) 38 (25.0%) 5 (62.5%) Primary therapy with radical intent (n) Radical prostatectomy 120 (75.0%) 114 (75.0%) 6 (75.0%) Associated with PLND 55 (34.4%) 50 (32.9%) 5 (62.5%) EBRT 16 (10.0%) 15 (9.9%) 1 (12.5%) Adjuvant/salvage radiotherapy (n) 88 (55.0%) 85 (55.9%) 3 (37.5%) Median time from primary radical treatment to PET/CT (y) 6.1 (IQR, 2.9–12.2) 6.1 (IQR, 2.8–12.6) 7.5 (IQR, 4.9–10.9) No. of prior systemic life-prolonging therapies (n)* No systemic therapy 81 (50.6%) 74 (48.7%) 7 (87.5%) 1 therapy line 38 (23.8%) 37 (24.3%) 1 (12.5%) 2 therapy lines 22 (13.8%) 22 (14.5%) 0 ≥3 therapy lines 19 (11.9%) 19 (12.5%) 0 At time of first PET/CT Median PSA (ng/mL) 11.7 (IQR, 2–68) 13.1 (IQR, 2.1–77) 1.0 (IQR, 0.5–4.1) Median PSA doubling time (mo) 5.2 (IQR, 2.9–10.6) 5.0 (IQR, 2.9–10.6) 6.4 (IQR, 5.9–12.3) >6 mo (n) 71 (44.4%) 66 (43.4%) 5 (62.5%) >10 mo (n) 43 (26.9%) 41 (27.0%) 2 (25.0%) Median PSA velocity (ng/nL/mo) 6.8 (IQR, 2.5–23.6) 7.8 (IQR, 2.7–25.5) 1.5 (IQR, 0.5–4.5) Ongoing second-line therapy (n) 19 (11.9%) 19 (12.5%) 0 Ongoing ADT (n)† 106 (66.3%) 101 (66.4%) 5 (62.5%) ↵* Excluding ADT.
↵† At time of PSMA ongoing ADT is < 90 d.
ADT = androgen deprivation therapy; EBRT = external beam radiation therapy; IQR = interquartile range; PET/CT = positron emission tomography/computed tomography; PSA = prostate-specific antigen; nm/mCRPC = nonmetastatic/metastatic castration-resistant prostate cancer; PLND = pelvic lymph node dissection; TNM = tumor, node, metastasis.
Site of relapse/metastasis No. of patients (n) Median SUVmax Min–max SUVmax Bones 100 (65.8%) 24.0 (IQR, 14.3–37.9) 3.8–127.0 Nodes* 91 (59.9%) 16.7 (IQR, 11.0–28.0) 2.1–138.0 Prostate bed relapse 32 (21.1%) 10.1 (IQR, 7.9–19.9) 3.0–68.0 Visceral 22 (14.5%) 17.5 (IQR, 6.0–27.0) 4.6–45.0 ↵* Pelvic and distant.
IQR = interquartile range; PET/CT = positron emission tomography/computed tomography; PSMA = prostate-specific membrane antigen; SUVmax = maximized standardized uptake value.
Variable No. of patients (n) Proportion of patients expressing PSMA* (n) Median SUVmax in lesion with highest value P Received systemic treatment before first PET/CT† 0.009 No 81 (50.6%) 74 (91.4%) 16.7 (IQR, 8.0–34.0) Yes 79 (49.4%) 78 (98.7%) 29.0 (IQR, 15.0–37.7) No. of prior therapy lines if received systemic treatment before first PET/CT 0.087 1 38 (23.8%) 37 (97.4%) 19.9 (IQR, 12.9–37.0) 2 22 (13.8%) 22 (100%) 32.4 (IQR, 20.4–37.0) 3 13 (8.1%) 13 (100%) 29.0 (IQR, 20.0–39.0) 4 6 (3.8%) 6 (100%) 25.9 (IQR, 9.8–38.0) Last systemic treatment before first PET/CT 0.698 Abiraterone or enzalutamide 28 (17.5%) 28 (100%) 24.2 (IQR, 13.9–39.0) Docetaxel or cabazitaxel 24 (15.0%) 23 (95.8%) 27.5 (IQR, 15.3–37.4) Palliative, [223Ra]Ra-NaCl or PSMA-RLT 27 (16.9%) 27 (100%) 30.0 (IQR, 17.0–39.0) Ongoing systemic treatment at time of first PET/CT 0.931 No 141 (88.1%) 133 (94.3%) 20.4 (IQR, 12.0–37.0) Yes 19 (11.9%) 19 (100%) 19.7 (IQR, 9.9–35.0) Second PET/CT 0.277 No 90 (56.3%) 86 (95.6%) 26 (IQR, 14–37) Yes 70 (43.8%) 66 (94.3%) 18 (IQR, 9.2–37.7)
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