Randomized Phase II Trial of Sipuleucel-T with or without Radium-223 in Men with Bone-metastatic Castration-resistant Prostate Cancer.
Journal
Clinical cancer research : an official journal of the American Association for Cancer Research
ISSN: 1557-3265
Titre abrégé: Clin Cancer Res
Pays: United States
ID NLM: 9502500
Informations de publication
Date de publication:
15 03 2021
15 03 2021
Historique:
received:
16
11
2020
revised:
18
12
2020
accepted:
11
01
2021
pubmed:
17
1
2021
medline:
8
2
2022
entrez:
16
1
2021
Statut:
ppublish
Résumé
To investigate whether radium-223 increases peripheral immune responses to sipuleucel-T in men with bone-predominant, minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). A total of 32 patients were randomized 1:1 in this open-label, phase II multicenter trial. Patients in the control arm received three sipuleucel-T treatments, 2 weeks apart. Those in the combination arm received six doses of radium-223 monthly, with sipuleucel-T intercalated between the second and fourth doses of radium-223. The primary endpoint was a comparison of peripheral antigen PA2024-specific T-cell responses (measured by proliferation index). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and PSA responses. We enrolled 32 patients, followed for a median of 1.6 years. Six weeks after the first sipuleucel-T dose, participants in the control arm had a 3.2-fold greater change in PA2024-specific T-cell responses compared with those who received combination treatment ( Our data raise the possibility of greater clinical activity with the combination of sipuleucel-T and radium-223 in men with asymptomatic bone mCRPC, despite the paradoxically lower immune responses observed. Additional study to confirm these findings in a larger trial is warranted.
Identifiants
pubmed: 33451978
pii: 1078-0432.CCR-20-4476
doi: 10.1158/1078-0432.CCR-20-4476
pmc: PMC8121020
mid: NIHMS1665735
doi:
Substances chimiques
Tissue Extracts
0
Radium-223
8BR2SOL3L1
sipuleucel-T
8Q622VDR18
Radium
W90AYD6R3Q
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
1623-1630Subventions
Organisme : NCI NIH HHS
ID : P30 CA006973
Pays : United States
Organisme : NIGMS NIH HHS
ID : U54 GM104940
Pays : United States
Commentaires et corrections
Type : CommentIn
Informations de copyright
©2021 American Association for Cancer Research.
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