The aim of this study is to determine the effectiveness and safety of ipatasertib (GDC-0068) in combination with abiraterone (Zytiga) and prednisone/prednisolone (Deltasone) in men with metastatic castration-resistant prostate cancer. The main outcome to be measured is time to disease progression.
Metastatic prostate cancer is cancer that has spread outside the prostate gland into surrounding organs. In some cases, this type of cancer can become resistant to treatments, such as hormone therapy (treatment that targets the male sex hormones, such as testosterone, involved in cancer growth). This is known as hormone-resistant cancer. Ipatasertib is a treatment that blocks a specific protein involved in cancer cell growth, movement and death. Abiraterone is a hormone therapy that stops the production of testosterone. Prednisone is used to treat swelling and inflammation in the body.
This study will examine the effectiveness of ipatasertib in combination with abiraterone and prednisone. The effectiveness will be measured as how long it takes for the cancer to progress.
Who are they looking for?
This study is recruiting 850 men over the age of 18 years. Men must have adequate organ function to be eligible for this trial. Those who are asymptomatic or men with mild symptoms will also be included. Participants must have a life expectency of more than 6 months, and must have ongoing hormone therapy within 28 days of starting the trial.
Men with existing medical conditions, including diabetes, uncontrolled high blood pressure, abnormal heart rhythms, lung or liver disease, are not eligible. Men with HIV or compromised immune systems are not eligible. Those who have recently undergone surgery will not be considered for selection. Men who have received chemotherapy for hormone-resistant prostate cancer or anti-cancer treatements will not be eligible.
How will it work
Patients will be randomly assigned to one of two groups. Group 1 will receive an oral tablet of ipatasertib daily on Day 1 of Cycle 1 until the cancer progresses or side-effects are too toxic. They will also receive an oral tablet of abiraterone, taken on an empty stomach, in combination with prednisone twice daily.
Group 2 will receive an oral placebo (substance with no active effect) tablet of daily on Day 1 of Cycle 1 until the cancer progresses or side-effects are too toxic. They will also receive an oral tablet of abiraterone, taken on an empty stomach, in combination with prednisone twice daily.
Patients will be followed for up to 65 months. Time to disease or symptom progression, as well as overall survival (time from treatment until death from any cause), will be measured.