Strontium Compared With Radiation Therapy in Treating Patients With Hormone-Refractory Prostate Cancer With Painful Bone Metastases
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|ClinicalTrials.gov Identifier: NCT00002503|
Recruitment Status : Completed
First Posted : May 20, 2004
Last Update Posted : September 24, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Prostate Cancer||Radiation: strontium chloride Sr 89||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||204 participants|
|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 Start Date :||October 1992|
|Actual Primary Completion Date :||November 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002503
|Study Chair:||G. O. N. Oosterhof, MD, PhD||Academisch Ziekenhuis Maastricht|