RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. This may be an effective treatment for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of strontium or radiation therapy in treating patients with prostate cancer that is refractory to hormone therapy who have painful bone metastases.
OBJECTIVES: I. Compare, in a randomized Phase III setting, the subjective response rate, time to progression, and survival of patients with hormone-refractory prostate cancer with painful osseous metastases treated with either strontium-89 or palliative local radiotherapy. II. Compare the quality of life achieved on these two regimens. III. Determine the toxicity and morbidity of treatment on these two regimens. IV. Compare the cost effectiveness of these two regimens. OUTLINE: Randomized study. Arm I: Radioisotope therapy. Strontium-89 chloride, Strontium-89. Arm II: Radiotherapy. Involved-field irradiation (equipment unspecified). PROJECTED ACCRUAL: 200 patients will be entered over 2 years.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
204
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
U.Z. Gasthuisberg
Leuven, Belgium
Aarhus Kommunehospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Ospedale B. Ramazzini
Carpi, Italy
Universita Degli Studi di Firenze - Policlin. di Careggi
Florence, Italy
Instituto Scientifico H.S. Raffaele
Milan, Italy
San Raffaele Hospital
Rome, Italy
...and 11 more locations
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.