This trial is examining the effectiveness of different hormone therapy regimes for patients whose prostate specific antigen (PSA; a protein elevated in prostate cancer) levels rise after prostate removing surgery. The main outcome to be measured will be the change in PSA levels.
The details
The best standard treatment for men with PSA rising after surgery includes radiation therapy combined with androgen deprivation therapy (ADT). ADT blocks hormones, such as testosterone, which prostate cancer uses to grow and spread. A common form of ADT is luteinizing hormone-releasing hormone agonist (LHRHA). This is often used with bicalutamide (Casodex), which helps the LHRHA block hormone function.
This study will examine whether two newer anti-hormonal drugs, abiraterone acetate (Zytiga) and apalutamide (ARN-509), combined with LHRHA can improve cure rates compared to using bicalutamide plus LHRHA. These two drugs work together to suppress both testosterone and the receptor where testosterone binds.
The outcome to be measured will be changes in PSA levels, as well as survival rates and side effects.
Who are they looking for?
This study will be recruiting 190 patients who have a PSA of 0.1 or more after prostate surgery. Participants must also have another high risk factor, such as positive lymph nodes, negative margins in surgery or local recurrence. Participants should have adequate blood values, and liver and kidney function.
Patients should not have active infections, brain metastases, gastrointestinal disorders, blood disorders, kidney disorders, seizures, or cardiovascular disease.
How will it work
Patients will be divided randomly into two groups. Both groups will receive ADT and radiation therapy. Group one will also receive bicalutamide and group two will also receive abiraterone acetate,apalutamide, and prednisone (a steroid).
PSA will be monitored using blood tests and patients will be followed up for five years.
