Real-World PSA Response and Safety Outcomes of 177Lu-PSMA-617 in Heavily Pretreated Metastatic Castration-Resistant Prostate Cancer: A Single-Center Retrospective Validation Study
- 1Department of Urology, Urological Science Institute, College of Medicine, Yonsei University, Seoul 03722, Republic of Korea
- 2Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, College of Medicine, Yonsei University, Seoul 03722, Republic of Korea
- 3Department of Nuclear Medicine, Severance Hospital, College of Medicine, Yonsei University, Seoul 03722, Republic of Korea
Abstract
Background/Objectives: 177Lu-PSMA-617 is an established standard-of-care treatment for eligible patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Treatment schedules and follow-up in routine practice may differ from clinical trial protocols. Post-approval evaluation is needed to determine whether trial-reported prostate-specific antigen (PSA) responses and adverse events are also observed outside trials. We assessed outcomes in heavily pretreated patients receiving 177Lu-PSMA-617. Methods: This retrospective study included 13 patients treated outside clinical trials at Severance Hospital, with follow-up through 30 June 2026. PSA50 and PSA90 denoted unconfirmed reductions of at least 50% and 90% from pretreatment baseline. Study-defined progression-free survival (PFS) included radiographic progression, a PSA increase of at least 50% from baseline considered disease progression, or death. Results: Median age was 69 years. All patients had received androgen-deprivation therapy, an androgen receptor pathway inhibitor, and docetaxel. Median baseline PSA was 88.79 ng/mL, and the median number of cycles was four. PSA50 and PSA90 occurred in six (46.2%) and three (23.1%) patients, respectively. Eight patients had a PFS event; median study-defined PFS was 5.9 months (95% confidence interval (CI), 1.4 months to not estimable). Two patients required activity reduction for cytopenias. Dry mouth was recorded in five patients (38.5%). Conclusions: PSA responses in this cohort support the applicability of trial findings to routine care. Documented adverse events included recognized toxicities. The PSA-inclusive PFS endpoint differs from trial radiographic PFS. Small sample size, concomitant treatment, and retrospective ascertainment limit interpretation. Larger cohorts with standardized follow-up are needed to assess response durability.
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BibTeX
@article{choi2026realworld,
title = {{Real-World PSA Response and Safety Outcomes of 177Lu-PSMA-617 in Heavily Pretreated Metastatic Castration-Resistant Prostate Cancer: A Single-Center Retrospective Validation Study}},
author = {Jin Hyeok Choi and Chang Gon Kim and Kyung Tak Oh and Ji Eun Heo and Jongsoo Lee and Won Sik Jang and Seung Hwan Lee and Young Deuk Choi and Seung Hoon Beom and Won Jun Kang and Woong Kyu Han and Hyunho Han},
journal = {Journal of Clinical Medicine},
year = {2026},
month = oct,
doi = {10.3390/jcm15207766},
url = {https://www.mdpi.com/2077-0383/15/20/7766},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Real-World PSA Response and Safety Outcomes of 177Lu-PSMA-617 in Heavily Pretreated Metastatic Castration-Resistant Prostate Cancer: A Single-Center Retrospective Validation Study
AU - Jin Hyeok Choi
AU - Chang Gon Kim
AU - Kyung Tak Oh
AU - Ji Eun Heo
AU - Jongsoo Lee
AU - Won Sik Jang
AU - Seung Hwan Lee
AU - Young Deuk Choi
AU - Seung Hoon Beom
AU - Won Jun Kang
AU - Woong Kyu Han
AU - Hyunho Han
PY - 2026
DA - 2026/10/01
JO - Journal of Clinical Medicine
DO - 10.3390/jcm15207766
UR - https://www.mdpi.com/2077-0383/15/20/7766
AB - Background/Objectives: 177Lu-PSMA-617 is an established standard-of-care treatment for eligible patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Treatment schedules and follow-up in routine practice may differ from clinical trial protocols. Post-approval evaluation is needed to determine whether trial-reported prostate-specific antigen (PSA) responses and adverse events are also observed outside trials. We assessed outcomes in heavily pretreated patients receiving 177Lu-PSMA-617. Methods: This retrospective study included 13 patients treated outside clinical trials at Severance Hospital, with follow-up through 30 June 2026. PSA50 and PSA90 denoted unconfirmed reductions of at least 50% and 90% from pretreatment baseline. Study-defined progression-free survival (PFS) included radiographic progression, a PSA increase of at least 50% from baseline considered disease progression, or death. Results: Median age was 69 years. All patients had received androgen-deprivation therapy, an androgen receptor pathway inhibitor, and docetaxel. Median baseline PSA was 88.79 ng/mL, and the median number of cycles was four. PSA50 and PSA90 occurred in six (46.2%) and three (23.1%) patients, respectively. Eight patients had a PFS event; median study-defined PFS was 5.9 months (95% confidence interval (CI), 1.4 months to not estimable). Two patients required activity reduction for cytopenias. Dry mouth was recorded in five patients (38.5%). Conclusions: PSA responses in this cohort support the applicability of trial findings to routine care. Documented adverse events included recognized toxicities. The PSA-inclusive PFS endpoint differs from trial radiographic PFS. Small sample size, concomitant treatment, and retrospective ascertainment limit interpretation. Larger cohorts with standardized follow-up are needed to assess response durability.
SN - 2077-0383
ER -