A Dose Optimization Study of Enzalutamide in Elderly Patients With Advanced Prostate Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSunnybrook Health Sciences Centre
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male aged 75 years or older.
Signed Informed Consent Form
High-risk biochemical recurrent hormone sensitive prostate cancer (high risk definition: PSA doubling time of ≤9 months and a PSA level of ≥2 ng per milliliter above nadir after radiation therapy or ≥1 ng per milliliter after radical prostatectomy with or without postoperative radiation therapy).
Metastatic castration-sensitive prostate cancer.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Enzalutamide Dose Escalation
DrugParticipants 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
DrugParticipants will continue to receive enzalutamide per standard of care.
Treatment groups
26 Participants
are divided into 2 treatment groupsGroup A: Main CohortExperimental treatment 1 intervention
Group B: Control CohortActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Enzalutamide Plasma Levels
To compare enzalutamide plasma concentrations in patients ≥ 75 years of age with younger patients at various dose levels.
Time frame
At day 29 and 57 of all applicable dose levels, up to 32 weeks maximum (4 levels, 8 weeks apart)Sponsors and contacts
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Source ClinicalTrials.gov
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