This trial is examining the effectiveness of radiation therapy, in treating patients with high-risk prostate cancer features after radical prostatectomy (surgery to remove the prostate gland).
The main outcome to be measured will be freedom from failure. Failure is evidence that the cancer has returned. Patients will be followed up for 5 years. This study is being conducted in Arizona, the United States.
The details
Hypofractionated radiation therapy (HFRT) and androgen suppression therapy (AST) are used in the treatment of prostate cancer. HFRT delivers higher doses of radiation therapy, over a shorter period of time. It may kill more tumor cells and have fewer side effects. Male hormones (androgens, the most common of which is testosterone) fuel the growth of prostate cancer. AST reduces the body's levels of androgens. This decreasing the size and slowing the growth of prostate cancer.
This trial is evaluating the effectiveness of HFRT in patients with high-risk prostate cancer after prostate surgery. The main outcome to be measured will be freedom from failure. Patients will be followed up for 5 years following treatment.
Who are they looking for?
This study requires 62 patients who have undergone a radical prostatectomy. Patients must be able to start treatment within 4 months of registering for this study. Patients from outside the USA may take part in this trial. Patients with stage T2 to T3b cancer are eligible to participate in this study. Patients must have one or more high-risk prostate cancer features. PSA levels must be between 0.2 and less than 2.
Patients must not have taken AST for longer than 6 months before the trial. Patients must not have active inflammatory bowel disease. Patients with a history of urinary retention will not qualify for this trial. Patients must not have had a heart attack or heart failure requiring treatment in the 6 months before the trial. Patients who have had another type of cancer in the past five years, or have less than 50% chance of surviving for 5 years will not qualify for this study. Patients taking blood thinners such as warfarin will be excluded. Patients with major psychiatric or major medical conditions also do not qualify for this trial.
How will it work
There will be three groups in this study. Group one will receive HFRT. Group 2 and 3 will receive both AST (for between 6 and 12 months) and HFRT at different doses. Radiation therapy will be given over a period of two weeks. Patients will be followed up for five years after treatment.
