Can side effects of enzalutamide be prevented by using a reduced dose for frail (m)CRPC patients?

Phase 1

• Conditions: (Metastatic) Castration Resistant Prostate Cancer (mCRPC); MedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-000779-33-NL
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-19
• Last Update Posted: 12 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

-Frail male patients with PC who will start enzalutamide treatment within label
-Age at least 18 years
-Patient who are able and willing to give written informed consent prior to screening and enrolment
-Patients from whom it is possible to collect blood samples and who are willing to answer the questionnaires
-Life expectancy of > 6 months
-Capable of understanding and answering Dutch tests and questionnaires, as determined by the investigator

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

-Other causes for cognition change:
- (change in dose of opioids/sedatives/benzodiazepines) during last 2 weeks before study)
-Use of psychostimulantia such as methylphenidate within 1 week of start of study
-Diagnosed with medical conditions that affect cognition: Dementia, Alzheimer disease, Parkinson’s disease, psychiatric disorders that affect cognition other than depression or anxiety complaints related to the disease
-Active infection or other comorbidities that may contribute to fatigue or cognition change within 4 weeks of study entry
-Clinical relevant anaemia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified