(Metastatic) Castration Resistant Prostate Cancer (mCRPC) MedDRA version: 21.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: LLT Classification code 10076506 Term: Castration-resistant prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Radboud University Medical Center
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the decrease in the CNS side effect fatigue in frail mCRPC patients treated with a reduced dose of enzalutamide (120mg OD) compared to the standard dose of enzalutamide (160mg OD) after 6 weeks of treatment;Secondary Objective: To determine the decrease in the CNS side effect fatigue in frail mCRPC patients treated with a reduced dose of enzalutamide (120mg OD) compared to the standard dose of enzalutamide (160mg OD) after 12 weeks, and 24 weeks of treatment -To determine cognition impairment in frail mCRPC patients treated with a reduced dose of enzalutamide(120mg OD) compared to the standard dose of enzalutamide (160mg OD) after six weeks,12 weeks and 24 weeks of treatment -To evaluate changes in depression score in frail mCRPC patients treated with a reduced dose of enzalutamide(120mg OD) compared to the standard dose of enzalutamide (160mg OD) after six weeks, 12 weeks and 24 weeks of treatment -To correlate exposure (Ctrough) of enzalutamide and N-desmethylenzalutamide to the measured CNS side effects -To determine the percentage(%) of subjects that remained on the allocated dose level until the end of the study -To evaluate the effect of dose reduction on treatment efficacy according to PCWG3;Primary end point(s): The primary aim is to show that a reduced dose (120mg OD) results in less fatigue (measured by the change in FACIT-fatigue subscale score) after 6 weeks of therapy compared to the standard dose (160mg OD) for frail metastatic castration resistant prostate cancer patients.;Timepoint(s) of evaluation of this end point: 6 weeks from start of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -To explore if the change in FACIT-fatigue subscale score is different between the two arms of the study from start of therapy; an early measurement of fatigue is performed at 6 weeks, and to explore if there remains a difference between the two arms from baseline - up untill 6 months of therapy, the questionnaire is repeated after 6 months of therapy. -To explore the change in FACIT-cognition subscale score over time: from baseline to 6 weeks, 12 weeks and 24 weeks after start of therapy between the two arms of the study (reduced dose vs standard dose) -To explore the change in GDS-15 subscale score over time: from randomization to 6 weeks, 12 weeks and 24 weeks after start of therapy between the two arms of the study (reduced dose vs standard dose) -To compare the percentage of patients that develop depression (score>5 ) on GDS-15 questionnaire between the two arms of the study (reduced dose vs standard dose) over time: after 6 weeks, 12 weeks and 24 weeks months after start if therapy -To correlate the change in side effects with plasma concentrations (Ctrough) of enzalutamide and N-desmethyl enzalutamide -To evaluate the proportion (%) of patients in control arm (standard dose) that remain on allocated dose level until the end of the study -To evaluate treatment efficacy for both arms of the study according to PCWG3;Timepoint(s) of evaluation of this end point: 6 weeks, 12 weeks and 24 weeks | — |
Countries
Netherlands
Contacts
Public ContactDepartment of Pharmacy
Radboud University Medical Center
Outcome results
None listed