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

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.