This trial is looking at blocking androgens (male sex hormones) with different medications in men with raised PSA (a blood marker of prostate cancer) levels after prostate surgery. The main outcome to be measured will be the length of time the patients survive without the cancer progressing. This study is being conducted in the United States.
The details
One treatment option for patients with this type of cancer is androgen deprivation therapy (ADT). This treatment blocks the production of male hormones like testosterone, responsible for cancer growth. However, some patients stop responding to this treatment (castration-resistant prostate cancer). Apalutamide blocks androgens from taking effect in the body. Surgery to remove the prostate, radiation therapy and chemotherapy (such as docetaxel) are also used.
PSA is a protein in the blood which is raised in prostate cancer. PSA-only disease is a raised PSA level without any signs of cancer.
This trial is examining the effectiveness of blocking androgens with different medications, in men with raised PSA levels after prostate surgery. The main outcome to be measured will be the length of time the patients survive without progression of the cancer. Patients will be followed up for 3 years.
Who are they looking for?
This study requires 42 patients with recurrent PSA-only prostate cancer after prostate surgery. Patients must have adequate liver, kidney and bone marrow function. Patients must have adequate testosterone levels (>100ng/dl) to participate in this trial. Patients must use contraception during the study, and for three months afterward. Patients must also have a persistently detectable, or rising PSA within 4 years of prostate surgery. The PSA level must be above 0.2ng/ml.
Patients with liver conditions, and those taking certain medications such as hormones, and biological medications within 2 weeks of the study start will be excluded. Patients must not have received hormone therapy for longer than one month previously. Patients should not have active infections, brain metastases, gastrointestinal disorders, or cardiovascular disease. Patients at risk of seizure will also be excluded. Patients must not have used another investigational drug within 30 days of the trial starting. Patients with a history of solid organ or stem cell transplantation, along with patients who received immunotherapy and radiation therapy will be excluded.
How will it work
There will be only one group. Each patient will receive apalutamide daily for 36 weeks. They will also receive standard ADT (chosen by their doctor), and radiation therapy (daily for 6-8 weeks, starting from week 9). On completion of radiotherapy, docetaxel will be given through the vein every three weeks for 6 cycles. Patients will be followed up for 3 years.
