Flutamide With or Without PROSTVAC in Non-metastatic Castration Resistant (M0) Prostate Cancer.
Oncologist
; 28(7): 642-e561, 2023 07 05.
Article
em En
| MEDLINE
| ID: mdl-37134294
ABSTRACT
BACKGROUND:
Before 2018, there was no standard of care for non-metastatic (M0) castration resistant prostate cancer nmCRPC. Androgen receptor antagonists (ARAs) were commonly used sequentially nmCRPC.METHODS:
This was a multicenter, randomized clinical trial comparing the ARA flutamide+/-PROSTVAC, a pox viral vaccine targeting PSA that includes T-cell co-stimulatory molecules. Eligible men had negative CT and Tc99 bone scans, and rising PSA on ADT. Previous treatment with ARA was a stratification factor. Patients were also evaluated for antigen-specific immune responses using intracellular cytokine staining.RESULTS:
Thirty-three patients randomized to flutamide and 31 to flutamide+vaccine. The median age was 71.8 and 69.8 years, respectively. The median time to treatment failure after a median potential follow-up of 46.7 months was, 4.5 months (range 2-70) for flutamide alone vs. 6.9 months (2.5-40; P = .38) with flutamide+vaccine. Seven patients in each arm had a >50% PSA response. Antigen-specific responses were similar in both arms (58% of patients in flutamide alone and 56% in flutamide+vaccine). The treatments were well tolerated. The most common side effect > grade 2 was injection site reaction seen in 29/31 vaccine patients which were self-limiting.CONCLUSION:
The combination of flutamide+PROSTVAC did not improve outcomes in men with nmCRPC compared with flutamide alone. (ClinicalTrials.gov Identifier NCT00450463).Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Neoplasias da Próstata
/
Neoplasias de Próstata Resistentes à Castração
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article