Trial Information

Outcomes Following Intensity Modulated Radiation Therapy With And Without Erectile Tissue Dose Sparing For Favorable To Intermediate Risk Prostate Cancer

OBJECTIVES:

Primary

- 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.

Secondary

- 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
metastasis.

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.