Outcomes Following Intensity Modulated Radiation Therapy With And Without Erectile Tissue Dose Sparing For Favorable To Intermediate Risk Prostate Cancer
- Compare erectile dysfunction in patients with stage T1b-T2c adenocarcinoma of the
prostate after treatment with intensity-modulated radiotherapy with vs without dose
sparing for erectile tissue.
- Compare biochemical freedom from failure rates, as a measure of prostate cancer
control, in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Determine the association of molecular markers and biochemical freedom from failure
rate and other endpoints in patients treated with these regimens.
OUTLINE: This is a randomized, single-blind study. Patients are stratified according to age
(≤ 65 vs > 65), prescription radiotherapy dose (74 Gy vs 76 Gy), and frequency of erection
during sexual activity within the past 4 weeks (a few times vs sometimes vs most times to
always). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily
5 days a week for approximately 7.5 weeks.
- Arm II: Patients undergo IMRT with dose restriction to erectile tissue once daily 5
days a week for approximately 7.5 weeks.
Treatment in both arms continues in the absence of unacceptable toxicity or disease
Quality of life is assessed at baseline, at 6 and 12 months, and then annually for 4 years
Patients are followed at 3 months and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this
study within 2.5 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Erectile dysfunction rates as measured by IIEF after treatment
6 month intervals after completion of radiotherapy for 5 years
Eric Horwitz, MD
Fox Chase Cancer Center
United States: Food and Drug Administration
|Fox Chase Cancer Center - Philadelphia||Philadelphia, Pennsylvania 19111-2497|