Flutamide With or Without PROSTVAC in Non-metastatic Castration Resistant (M0) Prostate Cancer.

Male Humans Flutamide / therapeutic use Prostate-Specific Antigen Prostatic Neoplasms, Castration-Resistant / drug therapy Prostatic Neoplasms / drug therapy Androgen Antagonists / therapeutic use Castration

anti-androgen therapy cancer vaccine immunotherapy prostate cancer

Journal

The oncologist

ISSN: 1549-490X

Titre abrégé: Oncologist

Pays: England

ID NLM: 9607837

Informations de publication

Date de publication:
05 07 2023

Historique:

received: 28 12 2022

accepted: 10 02 2023

medline: 7 7 2023

pubmed: 3 5 2023

entrez: 3 5 2023

Statut: ppublish

Résumé

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. 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. 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. The combination of flutamide+PROSTVAC did not improve outcomes in men with nmCRPC compared with flutamide alone. (ClinicalTrials.gov Identifier: NCT00450463).

Sections du résumé

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).

Identifiants

DOI: 10.1093/oncolo/oyad058 PMID: 37134294 PMC: PMC10322134

pubmed: 37134294

pii: 7150994

doi: 10.1093/oncolo/oyad058

pmc: PMC10322134

doi:

Substances chimiques

Flutamide 76W6J0943E

PROSTVAC 0

Prostate-Specific Antigen EC 3.4.21.77

Androgen Antagonists 0

Banques de données

ClinicalTrials.gov

['NCT00450463']

Types de publication

Randomized Controlled Trial Multicenter Study Journal Article Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

642-e561

Informations de copyright

Published by Oxford University Press 2023. This work is written by (a) US Government employee(s) and is in the public domain in the US.

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