This trial is examining how effective different treatments are at shrinking the prostate cancer before surgery. The main outcomes to be measured will be a complete response (complete disappearance of cancer) and minimal residual disease (almost undetectable cancer). This study is being conducted in Massachusetts and New York, the United States.
The details
Most prostate cancers respond to hormonal therapy. This treatment reduces the male hormone levels in the body that normally fuel cancer growth. This can shrink prostate cancer before surgery. It might reduce the chances of the cancer coming back in the future.
Other treatments for prostate cancer can include surgery to remove the tumor and radiotherapy. Studies have shown that any single approach on its own will not control or get rid of the cancer. This is especially true of patients with high risk, or aggressive cancer features.
This trial is examining how effective different treatments are at shrinking prostate cancer before surgery. The main outcome to be measured is the complete response rate and minimal residual disease. Patients will be followed up for 2 years.
Who are they looking for?
This study requires 76 patients with very high-risk prostate cancer. Their tumors must be considered not removable by surgery. Patients must have adequate liver, kidney and bone marrow function to participate in this trial. Patients must use contraception and not donate sperm during the study, and for three months afterward.
Patients must not have had surgery to remove the cancer or radiation therapy. Patients with liver conditions, diabetes and those taking drugs that reduce the immune response (such as certain doses of steroids) will be excluded. Patients should not have active infections (this may include hepatitis or HIV), brain metastases, gastrointestinal disorders, or cardiovascular disease. Patients at risk of seizure will also be excluded. Patients must not have used another experimental drug within 30 days of the trial starting. Patients with a second form of cancer, or who have received treatment for cancer in the last five years will be excluded. Patients with a life expectancy of fewer than 5 years will be excluded.
How will it work
There will be 2 groups in this study. One group will receive hormone reducing therapies chosen by the doctor and apalutamide (Erleada; a hormonal treatment), abiraterone acetate (Zytiga; a hormonal treatment), and prednisone (Deltasone; a corticosteroid drug). Both groups will also have surgery to remove the prostate and lymph nodes. Patients will be followed up for 2 years.
