This phase 2 trial is examining the effectiveness and safety of trametinib (Mekinist) in patients with metastatic castration-resistant prostate cancer (mCRPC; prostate cancer which has spread from its original place to another area in the body and keeps growing even when the amount of testosterone in the body is reduced to very low levels). The main outcome to be measured will be the prostate-specific antigen (PSA) response rate. This is a more than 50% drop in PSA level after treatment. PSA is a marker for cancer progression. This trial is recruiting in California, US.
A treatment option for patients with mCRPC is with androgen deprivation therapy (ADT; blocks the action of the hormone testosterone which helps the cancer to grow). An alternative is to treat with trametinib. This targeted therapy drug causes cancer cell death and inhibits the cells multiplying. It is not known if trametinib is more effective and safe at treating mCRPC.
This study is being done to investigate the effectiveness and safety of trametinib in patients with mCRPC. The main outcome to be measured will be the PSA response rate after a 24-week follow-up.
Who are they looking for?
62 participants with mCRPC will be recruited. Patients must have a biopsy to confirm mCRPC. Participants must have progressed on at least 1 other treatment option. Participants must have normal liver, kidney, blood cell levels and have a normal electrocardiogram.
Patients cannot participate if they have had a blood clot in the eye veins or an abnormal eye exam. They must not have an abnormal heart exam or lung disease. They must not have cancer spread to the brain or spinal cord, be allergic to the treatment or have another cancer within the last 5 years. They must not have had recent surgery or radiotherapy.
How will it work
There will be one group. All patients will receive trametinib by mouth once a day and will be followed up at 24 weeks.