The aim of this trial is to determine the effectiveness of a combination of the chemotherapies docetaxel (Taxotere) and carboplatin (Paraplatin) in advanced (spread beyond the prostate) prostate cancer. The main outcome to be measured is the number of patients who experience a decrease of 50% in prostate specific antigen levels (PSA – protein elevated in the blood in the presence of prostate cancer) after treatment. This study is being conducted in Seattle, Washington, and Los Angeles, California.
The details
Chemotherapy is a common treatment used in prostate cancer. Docetaxel and carboplatin are chemotherapy drugs that work by preventing cancer cells from growing and spreading to other parts of the body. This combination has been effective against other forms of cancer. Recent studies have shown that they may also be beneficial in treating advanced, hormone-resistant prostate cancer with certain genetic mutations. Hormone resistant cancer is cancer that will no longer respond to hormone therapy. Hormone therapy targets the male sex hormones active in cancer, such as testosterone. Mutations in certain genes, such as BRCA, make it easier for cancer cells to grow.
The current trial will examine the effectiveness of docetaxel and carboplatin in men with advanced, hormone-resistant prostate cancer with genetic mutations in certain genes. The main outcome will be measured through PSA blood testing.
Who are they looking for?
This trial is recruiting 35 men with confirmed advanced prostate cancer, who have received or are undergoing current hormone therapy or chemotherapy. Patients with adequate organ function will also be considered. Patients with inactive BRCA1, BRCA2 or ATM genes will also be eligible.
Patients with co-existing cancer or diseases (liver disease, heart disease, mental illness) that will affect the results of this trial will not be considered. Patients currently receiving an investigational drug will not be eligible for selection.
How will it work
Patients will receive 60 mg/m2 of docetaxel on Day 1 of each 21-day cycle. Carboplatin will also be administered on Day 1 of each 21-day cycle. Both drugs should be administered over 30 minute periods. This will be repeated until the cancer progresses or side-effects become intolerable.
