Randomized Trial of External Beam Radiation With or Without Short-Course Hormonal Therapy in Intermediate Risk Prostate Cancer Patients

Prior patient studies have shown that short-term hormone therapy (about 4 months) before and during radiation therapy can benefit patients with bulky tumors or locally-advanced prostate tumors. These prior results have been used to justify a potential benefit for using short-term hormone therapy combined with radiation therapy for patients with less bulky or less advanced prostate cancers. However, the combination of hormone therapy and radiation has not been shown to definitively benefit patients with your level of prostate cancer. Furthermore, these older studies used relatively low doses of radiation by today's standards, and hormone therapy may be of no benefit when using higher doses of radiation. Researchers want to study the use of combination hormone therapy and radiation therapy in the treatment of your level of prostate cancer.

If you are eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of 2 treatment groups. There is an equal chance of being assigned to either treatment group.

If you are assigned to Group 1, you will receive high-dose radiation treatment given over about 8 1/2 weeks. During this period, you will receive up to 42 treatments, 5 days per week with 2 days rest in between. There will be no treatment on weekends. This is the current standard schedule of treatment for prostate cancer patients. A radiation treatment planning session will be done before the actual radiation treatments. This planning session will be used to get images of your prostate and other pelvic organs to help plan the radiation fields. The planning session involves a computed tomography (CT) scan that takes about 40-45 minutes. During this time, about 3 special, permanent tattoo marks will be placed on your skin using ink. The tattoo marks will help with daily setup and positioning of the radiation fields. These marks are small and about the size of a freckle.

If you are assigned to Group 2, you will receive the same radiation therapy as participants in Group 1, but you will also receive hormone therapy with bicalutamide (Casodex) and either leuprolide (Lupron) or goserelin (Zoladex). The hormone therapy includes a total of 2 injections or shots (leuprolide or goserelin) given every 3 months and a pill (bicalutamide) that is taken once per day for the first 21 to 30 days. Flutamide, which is taken three times per day for the first 21-30 days, may be used instead of bicalutamide. The choice of hormone therapy will be left up to your treating physician. You will receive hormone therapy for a full 6 months. Hormonal treatment will begin about 2 months before radiation therapy is due to start and continue for 2 months during radiation therapy, with the last phase of hormone treatment for 2 months after radiation therapy.

No matter which group you are assigned to, you will be given questionnaires to study health-related quality of life. These questionnaires will take about 15 minutes to complete and will be given to you before therapy begins. Within 1-2 weeks before starting radiation therapy, you will answer a health-related quality of life questionnaire (Expanded Prostate Cancer Index Composite-SF12-AUASI). Participants who are receiving hormonal therapy will also be given this questionnaire within one week before hormonal therapy. During radiotherapy, you will be examined every week, and severe side effects and reactions will be recorded using the modified acute toxicity scale. During radiotherapy, you also will be given the EPIC-26 Short Form at Weeks 4 and 8.