This study aims to examine the effectiveness of niraparib (Zejula) combined with hormone therapy and radiotherapy to treat patients with high-risk prostate cancer. The main outcome to be measured will be how long patients remain cancer-free. This study is recruiting in Philadelphia, PA.
Prostate cancer occurs mostly in men over 50. There are several stages of prostate cancer. High-risk prostate cancer, in particular, is harder to treat. Currently, treatment usually includes hormone therapy and radiotherapy. Niraparib is an anti-cancer drug which has shown success in killing ovarian cancer.
This study aims to see if niraparib can help boost the effects of hormone therapy and radiotherapy in killing prostate cancer. The main outcome to be measured is how long the patients remain cancer-free.
Who are they looking for?
This study is recruiting 180 patients with high-risk adenocarcinoma of the prostate. Patients must have a Gleason score (a classification based of cancer aggressiveness) 7 or higher. Patients should have good levels of red blood cells, white blood cells, and platelets. Patients should have good kidney and liver function. Patients must agree to use contraception for the duration of the trial and for at least 3 months afterward.
Patients should not have secondary tumors in other parts of the body. Patients who previously received surgery for prostate cancer cannot participate. Patients who previously received radiotherapy for the prostate tumor cannot participate. Patients who suffer from heart disease cannot participate. Patients with infections including HIV cannot participate.
How will it work
Patients will be recruited in two phases. Patients in phase 1 will all receive niraparib with hormone therapy and radiotherapy. Patients in phase 2 will be divided into two groups. The first group will receive hormone therapy and radiotherapy. The second group will receive niraparib, hormone therapy, and radiotherapy.
The length of time patients remain cancer-free will be measured for 2 years. Patients will also be evaluated for 3 years to assess how many survive, how many have no prostate cancer and how many develop more severe cancer. Patients will also be checked for side effects and gene changes for 3 years.