The aim of this trial is to determine the effect of the hormone therapy apalutamide (ARN-509) with or without abiraterone acetate (Zytiga), GnRH agonists or prednisone and whether they improve prostate surgery outcomes in men with high-risk prostate cancer. The outcomes to be measured include erectile function, continence, and effect on tumor size and recurrence.
The details
Hormone therapy is a standard treatment option for prostate cancer. This therapy usually involves either surgical castration (surgical removal of the testicles) or medical castration (hormonal therapy), intended to reduce the production of androgens (male sex hormones such as testosterone), or inhibit their effect on cancer cell growth. Prostate surgery is another treatment option. This involves surgically removing the prostate gland. There are different types of surgery options. Nerve-sparing prostate surgery is designed to maintain sexual function following the procedure.
Several drugs can be used in hormone therapy, including gonadotropin-releasing hormone agonists (GnRH agonist) and anti-androgens. GnRH agonists are hormone therapy drugs that lower the production of testosterone in a man's body. Anti-androgens block the action of androgens (hormones). Apalutamide and abiraterone acetate are anti-androgens. Prednisone is used to treat inflammation.
This study will examine the benefit of these therapies in improving prostate surgery outcomes. The outcomes measured will include erectile function, continence, response to treatment, and quality of life.
Who are they looking for?
This trial is currently recruiting 90 men. Participants must have a Gleason score of more than 8 or a PSA value of more than 20. Men must have normal to near normal blood values. Men enrolling must agree to use adequate contraception with their partner throughout the trial to prevent pregnancy.
Men with stage 4 (spread into distant organs) prostate cancer in the rectum or ureters will not be eligible. Men with medical conditions that may affect the results of the trial will not be eligible. This includes seizure disorders, heart disease, stroke, or liver disease.
How will it work
Patients will be randomly assigned to one of three groups. Group 1 will receive apalutamide daily for 3 months. This will be followed by prostate surgery. Group 2 will receive a GnRH agonist on Day 1, apalutamide daily for 4 doses, abiraterone acetate daily for 4 doses and prednisone daily for 3 months. Group 3 will receive only prostate surgery only.
