Estudio observacional de darolutamida en pacientes con cáncer de próstata resistente a la castración no metastásico

Activo, no reclutaClinicalTrials.gov

ID: NCT04122976Tipo: OBSERVATIONALInicio: 30 de ene de 2020Fin estimado: 7 de oct de 2026

Resumen

El propósito de este estudio es determinar, en condiciones de práctica clínica habitual, si darolutamida es segura y eficaz para pacientes con diagnóstico de cáncer de próstata que no se ha diseminado a otras partes del organismo. Cuando un paciente es incorporado al estudio, su médico ya habrá tomado la decisión de tratarlo con darolutamida de acuerdo con la práctica estándar local.

Elegibilidad

Edad mínima: 18 YearsSexo: MALE

Criterios de inclusión

Men over the age of 18 years
Histologically or cytologically confirmed adenocarcinoma CRPC defined by disease progression despite ADT and may present as a confirmed rise in serum PSA levels (as defined by PCWG3: Rising PSA values at a minimum of 1-week intervals, and a baseline PSA value ≥ 1.0 ng/mL). For patients with a prior ARi treatment (Enzalutamide or Apalutamide), there is no baseline PSA value required
No evidence of metastasis based on conventional imaging. An imaging assessment needs to be obtained prior to the 1st dose of darolutamide. For patients with a prior ARi treatment (Enzalutamide or Apalutamide) for nmCRPC, M0 status with no evidence of disease progression should be confirmed within 3 months of ARi discontinuation
Decision to initiate treatment with darolutamide was made as per investigator's routine treatment practice prior to enrollment in the study
Signed informed consent
Life expectancy of ≥3 months
For a patient with a prior ARi treatment (Enzalutamide or Apalutamide) for nmCRPC for less than one year, all toxic effects from prior use of any ARi treatment have to be resolved at the time of enrollment and prior to the 1st dose of darolutamide

Criterios de exclusión

Participation in an investigational program with interventions outside of routine clinical practice
Contraindications according to the local marketing authorization
Previous treatment with darolutamide (more than 3 days prior to enrollment)
Patient with a prior ARi treatment (Enzalutamide or Apalutamide) for nmCRPC for more than one year

Intervenciones

drug

Darolutamide(Nubeqa, BAY1841788)

The decision on the dose and duration of treatment is solely at the discretion of the treating physician, based on the recommendations written in the local product information.

Ubicaciones

Many Locations

Multiple Locations, Argentina

Patrocinadores

PrincipalBayer

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

Estudio observacional de darolutamida en pacientes con cá... | EligiMed