NCT03927391CompletedPhase 4
Effect of a Reduced Dose Enzalutamide in Frail (m)CRPC Patients on Cognitive Side Effects
Effect of a Reduced Dose on Cognitive Side Effects of Enzalutamide in Frail (Metastatic) Castration-resistant Prostate Cancer Patients (REDOSE)
Source: ClinicalTrials.gov · Last updated 12 Jun 2024
Brief summary (registry, in English)
Prostate cancer is the most commonly diagnosed cancer among men in Western countries. When the disease recurs as castration-resistant prostate cancer (CRPC) it is associated with a median overall survival of approximately 2 years with significant decrement in quality of life due to additional cancer-specific and treatment-induced morbidity. Palliative agents currently used in the CRPC setting include the 2nd generation hormonal agents abiraterone acetate and enzalutamide but also radium-223, docetaxel and cabazitaxel. Choices for treatment strategies are based on multiple factors such as age, co-morbidity and drug toxicity profile. The side effect profile of enzalutamide is associated with central nervous system (CNS side effects) such as fatigue and depression. The mechanism for these side effects is not yet fully understood, but it was shown in rodent studies that enzalutamide and its active metabolite penetrate into the CNS. This might cause the CNS side effects that were later seen in the phase 1 study where fatigue was found to be a dose-dependent adverse event. After dose reductions the symptoms resolved. This was also found in a retrospective study of Japanese metastatic CRPC (mCRPC) patients (n=345) in which the side effects malaise and nausea decreased remarkably after dose reduction. However, no exposure-response relation was observed in the study of Gibbons et al. Additionally, based on the data of the phase 1 trial of enzalutamide it can be suggested that a minimum trough concentration of 5.0 mg/L could be considered as a target for exposure to enzalutamide. In particular, frail (m)CRPC patients are more prone to develop CNS side effects on enzalutamide. The investigator's hypothesis is that dose reduction to 75% (120mg) can be safely done to treat (m)CRPC in these patients with preserving optimal efficacy and less CNS side effects.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 57 (actual)
- First submitted
- 29 Mar 2019
- Start date
- 30 May 2019
- Primary completion date
- 8 Jan 2024
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Prostate cancer
- NCT number
- NCT03927391
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 57
- From 30 May 2019 to the primary completion date, 8 Jan 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- change in dose of opioids/sedatives/benzodiazepines during last 2 weeks before study)
Other illness
- 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 REDOSE, February 2019 Page 7 of 53 fatigue or cognition change within 4 weeks of study entry
- Hypersensitivity to the active substance or to any of the excipients.
Other
- Use of psychostimulants such as methylphenidate within 1 week of start of study
- Clinical relevant anaemia
- MoCa score \<20
Who the study is looking for
- Frailᵃ male patients with prostate cancer who will start treatment with enzalutamide within label
- Age at least 18 years
- Patient who are able and willing to give written informed consent prior to screening
- Patients from whom it is possible to collect blood samples
- Patients who are willing to answer the questionnaires and test
- Life expectancy of \> 6 months
- Capable of understanding and answering Dutch tests and questionnaires, as determined by the investigator
- ᵃ Frail is defined as:
- a score on the comprehensive G8 assessment with cut-off ≤14 points and
- score ≥grade 1 for Central Nervous Disorders according to the Common Toxicity Criteria Adverse Event (CTCAE) criteria, of one of the following: Fatigue, Concentration impairment, cognitive disturbance, amnesia, depressed level of consciousness, memory impairment, hypersomnia.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CWZ Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| Franciscus Gasthuis en Vlietland hospital Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.