Effect of Enzalutamide Dose Reduction on Fatigue, Cognition, and Drug Trough Levels in Patients With Prostate Cancer

Phase 2

• Conditions: Prostate Cancer
• Interventions: Drug: Enzalutamide

• Registration Number: NCT03124615
• Lead Sponsor: Macquarie University, Australia

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-04
• Study First Submitted: 2017-04-13
• Study First Submitted QC: 2017-04-20
• Last Update Submitted: 2017-04-20
• Study First Posted: 2017-04-24
• Last Update Posted: 2017-04-24
• Study Start: 2017-05
• Primary Completion: 2020-12
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 47

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enzalutamide	Enzalutamide	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

Primary Outcome Measures

Name	Time	Method
The proportion of patients who have an improvement in cognition/ fatigue symptoms	1 year post enrolment	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.

Trial Locations

Locations (1)

Macquarie University; 🇦🇺 North Ryde, New South Wales, Australia