The aim of this study is to determine the benefit of a combination of treatments (chemotherapy, radiation therapy, and hormone therapy) in men with oligometastatic prostate cancer after prostate surgery (surgical removal of the prostate gland). The main outcome to be measured is the safety of this combination.
The details
Oligometastatic prostate cancer is cancer that no longer confined to the prostate gland, but has not yet spread into surrounding organs. Numerous treatments are available, such as hormone therapy, radiation therapy, and chemotherapy.
Hormone therapy, or castration therapy, is the standard of care for advanced prostate cancer. Hormone therapy usually involves either surgical castration (surgical removal of the testicles) or medical castration (hormonal therapy), intended to reduce the production of male sex hormones such as testosterone, or inhibit their effect on cancer cell growth. This can include treatment with hormone drugs, such as bicalutamide (Casodex) or leuprolide acetate (Lupron – administered through an IV). Radiation therapy focuses beams of radiation at the tumor site to kill cancer cells. Chemotherapy uses drugs to treat prostate cancer, such as docetaxel (Taxotere).
In some cases, hormone therapy and chemotherapy can be combined (chemohormonal therapy) to improve treatment outcomes. Systemic chemohormonal therapy is usually used when the cancer has spread outside the prostate. It is also used in men who have high-risk localized disease (confined within the prostate gland).
This study will examine the safety and effectiveness of the combination of chemotherapy, hormone therapy, and radiation. The main outcome will be measured as the number of side effects experienced, and the time to disease progression.
Who are they looking for?
This study is currently enrolling 33 men with oligometastatic prostate cancereligible.
Men who have received previous non-surgical treatments, or are receiving ongoing systemic treatment will not be eligible. Men with co-existing diseases or illnesses that will affect trial results will not be eligible. This can include heart, liver, mental diseases or other cancers.
How will it work
After prostate surgery, patients will receive 6 months of docetaxel (Taxol) chemotherapy and the hormonal therapy leuprolide acetate. Radiation therapy will begin in month 7.
Patients will receive 50mg of bicalutamide orally throughout the study. This will be in addition to 22.5mg of leuprolide acetate administered via intramuscular injection every 3 months and 75mg of docetaxel, given through an IV on Day 1 every 3 weeks for up to 6 cycles.
Radiation will be delivered in 1 to 5 treatments. The dose and frequency will be dependent on the size and location of the tumor. Doses usually range from 16-24 Gy (unit of measurement for radiation) in 1 treatment, 48-50 Gy in 4 treatments, and 50-60 Gy in 5 treatments.
Hormone therapy will be continued for up to 2 years. Patients will be followed for up to 5 years.
