A Phase III Intensity Radiotherapy Dose Escalation for Prostate Cancer Using Hypofractionation
Patients in this study will be randomly picked (as in the toss of a coin) to be in one of
two treatment groups. There is an equal chance of being in either group.
Patients in Group 1 will be treated with intensity modulated radiotherapy (IMRT). These
patients will receive 42 treatments, 5 days per week, over 8.5 weeks. This method has become
the standard treatment at M.D. Anderson Cancer Center.
Patients in Group 2 will also be treated with IMRT. However, these patients will only
receive 30 treatments, 5 days per week, over 6 weeks. The dose per day for Group 2 patients
is higher than for Group 1 and has the possibility of killing more tumor cells.
Each external beam treatment requires about 10-20 minutes. However, patients can expect to
spend 20 - 30 minutes on the treatment table because imaging measurements of prostate
position will be done before each treatment. The total time in the radiation department each
treatment day will be about an hour.
After the radiotherapy is completed, patients will have a PSA blood test every 3 months for
2 years, then every 6 months for Years 3 - 5, then annually. They will be examined every 6
months during the first 2 years beginning 3 months after the completion of treatment, then
annually. A needle biopsy of the prostate will be performed if these tests suggest
This is an investigational treatment. 225 patients will take part in this study. This study
will take place at M. D. Anderson and possibly some affiliated hospitals.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Incidence of Rising PSA
PSA every 3 months for the first 2 years; every 6 months for years 3-5; and yearly thereafter
Deborah A. Kuban, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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