This phase 2 trial aims to evaluate the side effects and how well abiraterone acetate (Zytiga), niclosamide (Niclocide), and prednisonework in treating patients with hormone-resistant prostate cancer. The main outcome to be investigated is treatment response. The trial is recruiting in Sacramento (California), USA.
The details
Hormone therapy is a first-line treatment for advanced prostate cancer. It works by reducing the levels of male hormones, such as testosterone, active in cancer growth. Over time, many men become resistant to treatment and no longer respond to standard hormone therapy. This is known as castration-resistant prostate cancer.
Abiraterone acetate is a type of secondary hormone therapy that has been found to be effective in castration-resistant prostate cancer. Niclosamideis being investigated as a drug that may block another signal that can cause prostate cancer cell growth. Early results suggest it is particularly effective for castration-resistant disease. Prednisoneis a steroid drug often given in combination with hormone therapy to help lessen inflammation.
This study will examine the benefit of the treatment combination abiraterone acetate, niclosamide, and prednisonefor castration-resistant prostate cancer. Side effects will be recorded and blood tests will record treatment response.
Who are they looking for?
This study will recruit about 40 men with castration-resistant prostate cancer. Testosterone levels must be very low (at castrate levels). Prostate cancer must be progressing after primary hormone therapy. Full blood counts will be evaluated before participation.
Patients cannot take part in the trial if the cancer has spread to the brain. Participants should discontinue any radiation therapy, investigational drug, supplement or chemotherapy at least 4 weeks before taking part. Previous treatment with the hormonal therapies abiraterone or ketoconazoleis not permitted. Other hormonal therapy (including bicalutamide, enzalutamide, flutamide, andnilutamide) or chemotherapy (docetaxel, cabazitaxel, ormitoxantrone) is allowed. Patients should not have a history of any heart disease, have hepatitis, HIV, an active infection, any other cancers that were active within the last 3 years (with the exception of treated skin cancer), or present with any significant or uncontrolled medical illnesses.
How will it work
All participants will receive the treatment combination abiraterone acetate, niclosamide, and prednisone. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable side effects.
The number of patients that show a treatment response (based on blood tests) of at least 50% will be recorded for up to 2 years. Survival and disease progression will also be measured, as will the rate of side effects and any changes in quality of life over a 2-year period.
