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.
After you finish radiation therapy, you will be given the EPIC-SF12-AUASI every 3 months for
the first year, every 6 months for the next 2 years, and then once a year after that. This
may be done in person, by phone or by mail.
Prostate specific antigen (PSA) and testosterone levels will be checked before therapy
begins. These blood tests will require about 1 teaspoon of blood. They will be checked
before radiation therapy begins, but will not be checked during your radiation treatment.
Your PSA and testosterone levels will be rechecked at 3 to 6 month intervals after the
radiation therapy is done for the first 2 years. PSA will be checked every 6 months for the
Years 3 and 4, and once a year for Year 5.
If you have worsening of disease or have intolerable side effects, you may elect to remove
yourself from the prescribed treatment, but you may still be followed as part of the study.
You will be asked to return for follow-up testing in the form of physical exam every 6
months for the first 2 years and once each year after that. The purpose of the follow-up
visits and tests is to check the response of your cancer to treatment. If the PSA or
physical exam shows that the disease has not gone away completely or has come back, you may
have repeat staging with a bone scan, pelvic CT or magnetic resonance imaging (MRI), and
repeat prostate biopsy.
You will be watched for the condition of your disease for at least 4-5 years with follow-up
visits and PSA tests. If you are willing to return for follow-up visits beyond 5 years,
then you will continue to receive long term follow-up and be observed and advised about your
illness, according to your individual needs.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Prostate Specific Antigen (PSA) Failures
Baseline + Post-radiation PSA levels at three month intervals for initial two years then every 6 months thereafter. Participants with a rising PSA and no evidence of local or distant recurrence considered PSA failures.
3 months up to 2 years
Andrew K. Lee, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|