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A Dose Optimization Study of Enzalutamide in Elderly Patients With Advanced Prostate Cancer
Sponsor: Sunnybrook Health Sciences Centre
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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
26
Start Date
2026-04
Completion Date
2027-12
Last Updated
2026-04-06
Healthy Volunteers
No
Interventions
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.
Standard of Care
Participants will continue to receive enzalutamide per standard of care.
Locations (1)
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada