PMID- 37827838
OWN - NLM
STAT- MEDLINE
DCOM- 20231204
LR  - 20240227
IS  - 1535-5667 (Electronic)
IS  - 0161-5505 (Print)
IS  - 0161-5505 (Linking)
VI  - 64
IP  - 12
DP  - 2023 Dec 1
TI  - (177)Lu-Prostate-Specific Membrane Antigen Therapy in Patients with Metastatic 
      Castration-Resistant Prostate Cancer and Prior (223)Ra (RALU Study).
PG  - 1925-1931
LID - 10.2967/jnumed.123.266125 [doi]
AB  - (223)Ra-dichloride ((223)Ra) and (177)Lu-prostate-specific membrane antigen 
      (PSMA) are approved treatments for metastatic castration-resistant prostate 
      cancer (mCRPC). The safety and effectiveness of sequential use of (223)Ra and 
      (177)Lu-PSMA in patients with mCRPC are not well described. This study aimed to 
      evaluate (177)Lu-PSMA safety and efficacy in patients with mCRPC previously 
      treated with (223)Ra. Methods: The radium-->lutetium (RALU) study was a 
      multicenter, retrospective, medical chart review. Participants had received at 
      least 1 (223)Ra dose and, in any subsequent therapy line, at least 1 (177)Lu-PSMA 
      dose. Primary endpoints included the incidence of adverse events (AEs), serious 
      AEs, grade 3-4 hematologic AEs, and abnormal laboratory values. Secondary 
      endpoints included overall survival, time to next treatment/death, and change 
      from baseline in serum prostate-specific antigen and alkaline phosphatase levels. 
      Results: Data were from 133 patients. Before (177)Lu-PSMA therapy, 56% (75/133) 
      of patients received at least 4 life-prolonging therapies; all patients received 
      (223)Ra (73% received 5-6 injections). Overall, 27% (36/133) of patients received 
      at least 5 (177)Lu-PSMA infusions. Any-grade treatment-emergent AEs were reported 
      in 79% (105/133) of patients and serious AEs in 30% (40/133). The most frequent 
      grade 3-4 laboratory abnormalities were anemia (30%, 40/133) and thrombocytopenia 
      (13%, 17/133). Median overall survival was 13.2 mo (95% CI, 10.5-15.6 mo) from 
      the start of (177)Lu-PSMA. Conclusion: In this real-world setting, (223)Ra 
      followed by (177)Lu-PSMA therapy in heavily pretreated patients with mCRPC was 
      clinically feasible, with no indication of impairment of (177)Lu-PSMA safety or 
      effectiveness.
CI  - (c) 2023 by the Society of Nuclear Medicine and Molecular Imaging.
FAU - Rahbar, Kambiz
AU  - Rahbar K
AD  - Department of Nuclear Medicine, University of Munster Medical Center, Munster, 
      Germany; rahbar@uni-muenster.de.
FAU - Essler, Markus
AU  - Essler M
AD  - Department of Nuclear Medicine, University Hospital Bonn, Bonn, Germany.
FAU - Eiber, Matthias
AU  - Eiber M
AD  - Department of Nuclear Medicine, Technical University of Munich, Munich, Germany.
FAU - la Fougere, Christian
AU  - la Fougere C
AD  - Department of Nuclear Medicine and Clinical Molecular Imaging, University 
      Hospital Tubingen, Tubingen, Germany.
FAU - Prasad, Vikas
AU  - Prasad V
AD  - Department of Nuclear Medicine, University of Ulm, Ulm, Germany.
FAU - Fendler, Wolfgang P
AU  - Fendler WP
AD  - Department of Nuclear Medicine, German Cancer Consortium University Hospital 
      Essen, Essen, Germany.
FAU - Rassek, Philipp
AU  - Rassek P
AD  - Department of Nuclear Medicine, University of Munster Medical Center, Munster, 
      Germany.
FAU - Hasa, Ergela
AU  - Hasa E
AD  - Department of Nuclear Medicine, Technical University of Munich, Munich, Germany.
FAU - Dittmann, Helmut
AU  - Dittmann H
AD  - Department of Nuclear Medicine and Clinical Molecular Imaging, University 
      Hospital Tubingen, Tubingen, Germany.
FAU - Bundschuh, Ralph A
AU  - Bundschuh RA
AD  - Department of Nuclear Medicine, University Hospital Bonn, Bonn, Germany.
FAU - Pabst, Kim M
AU  - Pabst KM
AD  - Department of Nuclear Medicine, German Cancer Consortium University Hospital 
      Essen, Essen, Germany.
FAU - Kurtinecz, Milena
AU  - Kurtinecz M
AD  - Bayer HealthCare Pharmaceuticals, Whippany, New Jersey.
FAU - Schmall, Anja
AU  - Schmall A
AD  - Bayer Consumer Care, Basel, Switzerland; and.
FAU - Verholen, Frank
AU  - Verholen F
AD  - Bayer Consumer Care, Basel, Switzerland; and.
FAU - Sartor, Oliver
AU  - Sartor O
AD  - Tulane Cancer Center, Tulane Medical School, New Orleans, Louisiana.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20231201
PL  - United States
TA  - J Nucl Med
JT  - Journal of nuclear medicine : official publication, Society of Nuclear Medicine
JID - 0217410
RN  - 5H0DOZ21UJ (Lutetium)
RN  - W90AYD6R3Q (Radium)
RN  - 0 (Radiopharmaceuticals)
RN  - EC 3.4.21.77 (Prostate-Specific Antigen)
RN  - 0 (Dipeptides)
RN  - 0 (Heterocyclic Compounds, 1-Ring)
SB  - IM
MH  - Male
MH  - Humans
MH  - *Prostatic Neoplasms, Castration-Resistant
MH  - Lutetium/therapeutic use
MH  - *Radium/adverse effects
MH  - Treatment Outcome
MH  - Retrospective Studies
MH  - Prostate/pathology
MH  - Radiopharmaceuticals/therapeutic use
MH  - Prostate-Specific Antigen
MH  - Dipeptides/adverse effects
MH  - Heterocyclic Compounds, 1-Ring/adverse effects
PMC - PMC10690117
OTO - NOTNLM
OT  - 177Lu-PSMA
OT  - 223Ra
OT  - metastatic castration-resistant prostate cancer
OT  - real-world practice
OT  - targeted alpha-therapy
EDAT- 2023/10/13 00:43
MHDA- 2023/12/04 12:42
PMCR- 2023/12/01
CRDT- 2023/10/12 21:42
PHST- 2023/07/13 00:00 [received]
PHST- 2023/09/17 00:00 [revised]
PHST- 2023/12/04 12:42 [medline]
PHST- 2023/10/13 00:43 [pubmed]
PHST- 2023/10/12 21:42 [entrez]
PHST- 2023/12/01 00:00 [pmc-release]
AID - jnumed.123.266125 [pii]
AID - 266125 [pii]
AID - 10.2967/jnumed.123.266125 [doi]
PST - epublish
SO  - J Nucl Med. 2023 Dec 1;64(12):1925-1931. doi: 10.2967/jnumed.123.266125.