NCT03124615

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: Macquarie University, Australia · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Enzalutamide	Enzalutamide is a FDA and Therapeutic Goods Administration (TGA, Regulatory Authority of therapeutic goods in Australia) approved treatment for castration resistant prostate cancer

Timeline

• Start date: 2017-05-01
• Primary completion: 2020-12-01
• Completion: 2021-06-01
• First posted: 2017-04-24
• Last updated: 2017-04-24

Locations

1 site across 1 country: Australia