Trial Information

Phase I/II Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer

OBJECTIVES:

- To assess the feasibility of radioimmunoguided intensity-modulated radiotherapy (IMRT)
for stage I-IV prostate cancer.

- To determine the toxicity and tolerance of this regimen in these patients.

- To determine the tumor response based on physical examination and serial measurements
of the serum prostate-specific antigen (PSA) levels in these patients.

- To determine the outcome of patients treated on this study with radioimmunoguided IMRT
compared to 2 control groups of patients treated at Mayo Scottsdale Clinic (MSC).

OUTLINE: Patients undergo radioimmunoguided intensity-modulated radiotherapy once daily, 5
days a week for 8½ weeks. Beginning the last week of radiotherapy, some patients receive
leuprolide acetate intramuscularly every 3-4 months or goserelin subcutaneously every 3
months for 6 months, 12 months, or until disease progression.

After completion of study treatment, patients are followed every 3-4 months for 1 year,
every 6 months for 4 years and annually thereafter