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
Qualifiers
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
Treatments tested in this trial
- Enzalutamide Dose Escalation
- Standard of Care
Treatment groups
26 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov