NCT07512076

A Dose Optimization Study of Enzalutamide in Elderly Patients With Advanced Prostate Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, single-centre, pragmatic, non-randomized, dose escalation study to evaluate optimal dose levels of enzalutamide in elderly patients using pharmacokinetic blood sampling concentrations.

Detailed description

Enzalutamide is an androgen receptor pathway inhibitor (ARPI) drug that is commonly used in prostate cancer. It is safe, effective, and is generally well tolerated by patients at the standard dose of 160mg, however researchers have seen that it may cause unfavorable side effects in elderly patients 75 and older such as fatigue and cognitive impairment that impact their quality of life more significantly than those under 75. To date there is limited research comparing differences in side effects and quality of life experienced by elderly patients on standard versus a lower dose of enzalutamide. Dose reductions are common, particularly in elderly patients, although they are not explicitly recommended on the drug label, and as a result this study seeks to build on the existing research and practice experience to evaluate how enzalutamide is metabolized in elderly patients and whether this difference warrants different dosing standards in these patients.

Conditions

• Prostate Cancer Patients
• Elderly Patients
• Pharmacokinetic Study

Interventions

Type	Name	Description
DRUG	Enzalutamide Dose Escalation	Participants will be allocated to receive one of 4 dose levels of enzalutamide; * Level 1: 40mg * Level 2: 80mg * Level 3: 120mg * Level 4: 160mg There will be 4 participants per dose level. After 8 weeks of treatment at the initial dose level, the study doctor will review treatment progress and may escalate to a higher dose level at their discretion. For each dose level participants move up to (if applicable), they will repeat this same 8 weeks of treatment and evaluation process.
DRUG	Standard of Care	Participants will continue to receive enzalutamide per standard of care.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-07-01
• Completion: 2027-12-01
• First posted: 2026-04-06
• Last updated: 2026-04-06

Locations

1 site across 1 country: Canada