Spots Global Cancer Trial Database for Strontium Compared With Radiation Therapy in Treating Patients With Hormone-Refractory Prostate Cancer With Painful Bone Metastases
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Trial Identification
Brief Title: Strontium Compared With Radiation Therapy in Treating Patients With Hormone-Refractory Prostate Cancer With Painful Bone Metastases
Official Title: A PROSPECTIVE MULTICENTER RANDOMIZED STUDY COMPARING STRONTIUM-89 CHLORIDE AND PALLIATIVE LOCAL FIELD RADIOTHERAPY IN PATIENTS WITH HORMONAL ESCAPED ADVANCED PROSTATIC CANCER
Study ID: NCT00002503
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
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
Ospedale di Circolo e Fondazione Macchi, Varese, , Italy
Groot Ziekengasthuis 's-Hertogenbosch, 's-Hertogenbosch, , Netherlands
Antoni van Leeuwenhoekhuis, Amsterdam, , Netherlands
Academisch Medisch Centrum, Amsterdam, , Netherlands
Academisch Ziekenhuis Groningen, Groningen, , Netherlands
University Medical Center Nijmegen, Nijmegen, , Netherlands
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, , Poland
Hospital Santa Maria, Lisbon, , Portugal
Medical Radiological Research Center, Obninsk, , Russian Federation
Inselspital, Bern, Bern, , Switzerland
Newcastle General Hospital, Newcastle Upon Tyne, England, United Kingdom
Contact Details
Name: G. O. N. Oosterhof, MD, PhD
Affiliation: Academisch Ziekenhuis Maastricht
Role: STUDY_CHAIR
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