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. The most effective combination of ADT treatments is still under investigation.
Patients in this study will receive one of three forms of ADT; apalutamide (Erleada), degarelix (Firmagon), or abiraterone acetate (Zytiga) with prednisolone (a steroid). The anti-hormonal drugs, abiraterone acetate, degarelix, and apalutamide work to suppress both testosterone and the receptor where testosterone binds. The effectiveness of these treatments will be measured by the change in PSA levels.
This study is investigating the efficacy of these anti-hormonal drugs. This will be measured using PSA as a marker of tumor activity. PSA (prostate-specific antigen) is a protein which is higher in men who have prostate cancer.
Who are they looking for?
This study is recruiting 504 patients should have histologically confirmed prostate adenocarcinoma with a biochemical recurrence (rise in PSA after surgery). Participants must have adequate organ function and must agree to use a condom during intercourse while on the study medications.
Patients should not have active infections, metastases, seizure disorders, uncontrolled high blood pressure, gastrointestinal disorders or cardiovascular disease.
How will it work
Patients will be randomly assigned to one of three different groups. One group will be treated with apalutamide, another with degarelix, and the last group will receive abiraterone acetate with prednisolone (a steroid). These medications will be taken for a year.
