Decreased biochemical progression in patients with castration-resistant prostate cancer using a novel mefenamic acid anti-inflammatory therapy: A randomized controlled trial.

clinical trial mefenamic acid nonsteroidal anti-inflammatory drugs prostate cancer prostate-specific antigen therapy

Journal

Oncology letters
ISSN: 1792-1074
Titre abrégé: Oncol Lett
Pays: Greece
ID NLM: 101531236

Informations de publication

Date de publication:
Jun 2020
Historique:
received: 19 07 2019
accepted: 13 11 2019
entrez: 12 5 2020
pubmed: 12 5 2020
medline: 12 5 2020
Statut: ppublish

Résumé

Prostate cancer (PCa) is the second most common non-dermatological cancer in men and is a growing public health problem. Castration-resistant disease (CRD) is the most advanced stage of the disease and is difficult to control. Patients with CRD may no longer accept conventional therapies as they are not in appropriate clinical conditions or they refuse to receive it. Given that inflammation is an essential component of CRD origin and progression, anti-inflammatory agents could be a therapeutic option with fenamates as one of the proposed choices. A prospective, randomized, double-blinded, 2-arm, parallel group, phase II-III clinical trial was performed involving 20 patients with CRD-PCa (with a prostate specific antigen level <100 ng/ml) that were undergoing androgen deprivation therapy (ADT) and did not accept any established treatment for that disease stage. In addition to ADT, 10 patients received placebo and 10 received mefenamic acid (500 mg orally every 12 h) for 6 months. The primary endpoint was the change in serum prostate-specific antigen (PSA) at 6 months. The PSA levels decreased significantly with mefenamic acid (an average 42% decrease), whereas there was an average 55% increase in the placebo group (P=0.024). In the patients treated with the placebo, 70% had biochemical disease progression (an increase of ≥25% in PSA levels), which did not occur in any of the patients treated with mefenamic acid (relative risk=0.12; 95% confidence interval, 0.01-0.85; P=0.033). There was a significant increase in quality of life (EQ-5D-5L score) and body mass index (BMI) with the experimental treatment. In conclusion, mefenamic acid administration decreased biochemical progression in patients with castration resistant PCa, improved their quality of life and increased their BMI. Future studies are required in order to strengthen the findings of the present clinical trial. Trial registration, Cuban Public Registry of Clinical Trials Database RPCEC00000248, August 2017.

Identifiants

pubmed: 32391109
doi: 10.3892/ol.2020.11509
pii: OL-0-0-11509
pmc: PMC7204620
doi:

Types de publication

Journal Article

Langues

eng

Pagination

4151-4160

Informations de copyright

Copyright © 2020, Spandidos Publications.

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Auteurs

José Guzman-Esquivel (J)

Department of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, Mexico.
Department of Research, General Hospital of Zone No. 1 IMSS, Villa de Alvarez, Colima 28983, Mexico.

Martha A Mendoza-Hernandez (MA)

Department of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, Mexico.

Daniel Tiburcio-Jimenez (D)

Department of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, Mexico.

Oscar N Avila-Zamora (ON)

Department of Research, Cancerology State Institute, Colima State Health Services, Colima 28085, Mexico.

Josuel Delgado-Enciso (J)

Department of Research, Foundation for Cancer Ethics, Education and Research of The Cancerology State Institute, Colima 28085, Mexico.

Luis De-Leon-Zaragoza (L)

Department of Research, General Hospital of Zone No. 1 IMSS, Villa de Alvarez, Colima 28983, Mexico.
Department of Research, Cancerology State Institute, Colima State Health Services, Colima 28085, Mexico.

Juan C Casarez-Price (JC)

Department of Research, General Hospital of Zone No. 1 IMSS, Villa de Alvarez, Colima 28983, Mexico.
Department of Research, Cancerology State Institute, Colima State Health Services, Colima 28085, Mexico.

Iram P Rodriguez-Sanchez (IP)

Molecular and Structural Physiology Laboratory, School of Biological Sciences, Autonomous University of Nuevo León, Monterrey, Nuevo León 64460, Mexico.

Margarita L Martinez-Fierro (ML)

Molecular Medicine Laboratory, Academic Unit of Human Medicine and Health Sciences, Autonomous University of Zacatecas, Zacatecas, Zacatecas 98160, Mexico.

Carmen Meza-Robles (C)

Department of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, Mexico.
Department of Research, Cancerology State Institute, Colima State Health Services, Colima 28085, Mexico.

Alejandro Barocio-Acosta (A)

Department of Research, Cancerology State Institute, Colima State Health Services, Colima 28085, Mexico.

Luz M Baltazar-Rodriguez (LM)

Department of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, Mexico.

Sergio A Zaizar-Fregoso (SA)

Department of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, Mexico.

Jorge E Plata-Florenzano (JE)

Department of Research, General Hospital of Zone No. 1 IMSS, Villa de Alvarez, Colima 28983, Mexico.
Department of Research, Cancerology State Institute, Colima State Health Services, Colima 28085, Mexico.

Iván Delgado-Enciso (I)

Department of Molecular Medicine, School of Medicine, University of Colima, Colima 28040, Mexico.
Department of Research, Cancerology State Institute, Colima State Health Services, Colima 28085, Mexico.

Classifications MeSH