This trial is comparing drug therapy and drug therapy with prostate surgery or radiation for the treatment of advanced prostate cancer. The main outcome to be measured is overall survival. This trial is recruiting in Houston (Texas), USA.
The details
Prostate cancer can be treated by medication, surgery or radiation. Medication aims to kill the prostate cancer cells chemically. Surgery aims to cut out the cancerous prostate tissue. Radiation therapy uses radio waves to kill the cancerous prostate tissue. Medication given after surgery or radiation therapy might prolong survival time.
The aim of this study is to see if giving medication after prostate surgery or radiation therapy will prolong survival time in patients with prostate cancer that has spread to other parts of the body. The main outcome to be measured is overall survival.
Who are they looking for?
1273 patients are needed for this trial. Patients should have adenocarcinoma of the prostate that has not received previous definitive treatment (surgery, radiation, cryotherapy). Patients must have had less than 28 weeks of medication before entering the trial. Cancer cannot have progressed while the patient is on medication.
Patients must not have any other active cancer.
How will it work
This study has two parts. In the first part (induction period) patients will receive an acceptable type of standard therapy for prostate cancer (drugs or removal of the testicles to stop the production of testosterone). Patients will remain on their respective regimens for 22 to 28 weeks.
After the induction phase, patients will be randomly allocated to one of two groups (randomization phase). Group 1 will receive one of the standard treatments for prostate cancer. Group 2 will have one standard treatment, followed by prostate removal 8 weeks after the randomization phase or radiation therapy within 4 weeks of randomization. Patients are then followed for 8 years to record survival.
