Clinical trial · Interventional
Effect of Enzalutamide Dose Reduction on Fatigue, Cognition, and Drug Trough Levels in Patients With Prostate Cancer
NCT03124615CI-TRIAL-00027147EFFECTunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary purpose of this trial is to determine whether dose reduction of enzalutamide in patients with grade 3 fatigue and/or cognition change will lead to an improvement in symptoms while maintaining active drug levels. Patients within 3 months of starting enzalutamide will be assessed by their oncologist as being potentially eligible for dose reduction due to the onset of moderate to severe fatigue and/or cognition change, which is assessed as being due to enzalutamide
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enzalutamide | Drug | Enzalutamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Enzalutamide
- description
- Patients will have commenced standard dose enzalutamide (160mg) daily and dose will be reduced if Grade 3 fatigue or cognition change has occurred and if toxicity is attributed to enzalutamide
- interventionNames
- Drug: Enzalutamide
Primary outcomes (1)
- measure
- The proportion of patients who have an improvement in cognition/ fatigue symptoms
- timeFrame
- 1 year post enrolment
- description
- The primary endpoint is an improvement in the fatigue and cognition symptoms. Improvement will be de ned as the patient answering 'Better' in the cognition/ fatigue question at the lowest dose of enzalutamide.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with prostate cancer who have commenced enzalutamide within 3 months 2. Patient must have concomitant LHRH agonist or antagonist (no single agent enzalutamide) 3. Receiving enzalutamide before or after docetaxel 4. Patients may have hormone-sensitive or castrate resistant disease 5. Patients may have metastatic (M1) or non-metastatic (M0) disease 6. Onset of grade 3 or more cognition change and/or fatigue after commencement of enzalutamide considered to be due to enzalutamide Exclusion Criteria: 1. Clinical dementia 2. Concomitant use of drugs known to impair cognition such as benzodiazepines or antihistamines. 3. Concomitant use of strong CYP3A4 and/ or CYP2C8 inducers or inhibitors. 4. Patient expected to have a change in opioid dose during the study period or have had a change 4 weeks before study entry. 5. Diagnosed with sleep apnoea 6. Brain metastases, prior seizures, drugs that significantly reduce seizure threshold. 7. Active infection or other intercurrent illness that may contribute to fatigue or cognition change within 4 weeks of study entry.
References
Publications (0)
Data not yet available
No reference posted for this study.