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NOT YET RECRUITING
NCT07512076
PHASE2

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

Sponsor: Sunnybrook Health Sciences Centre

View on ClinicalTrials.gov

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

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.

Locations (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada