A Dose Optimization Study of Enzalutamide in Elderly Patients With Advanced Prostate Cancer (NCT07512076)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (14 items) and avoid the listed exclusions (14 items).
Location: Sunnybrook Health Sciences Centre — Toronto, Ontario
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: Main Cohort:
- Metastatic castration-resistant prostate cancer
- Pain related to bone metastasis requiring the use of opioid analgesics
- Impending spinal cord compression related to metastasis to vertebral column
- Painful femoral neck or any other metastasis judged to be at risk of short-term pathological fracture in the investigator's opinion
- Co-administration of medications which are moderate to strong CYP2C8 inducers or inhibitors
- Co-administration of medications which are moderate to strong CYP3A4 inducers or inhibitors
- History of seizure disorder
- History of moderate-severe dementia
- Performance status \> ECOG 2
- Uncontrolled hypertension (defined as sustained systolic blood pressure above 160 and/or diastolic above 100 despite the adequate use of antihypertensive medication)
- Participants with a known history of dementia, seizure disorder, intracranial lesions, moderate to severe hepatic impairment, stage ≥ 3 chronic renal failure or stroke will also be excluded Control Cohort:
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Sunnybrook Health Sciences Centre — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (416) 480-4617
Email: daniel.khalaf@sunnybrook.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.