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Strontium Compared With Radiation Therapy in Treating Patients With Hormone-Refractory Prostate Cancer With Painful Bone Metastases

Phase 3
Completed
Conditions
Metastatic Cancer
Prostate Cancer
Registration Number
NCT00002503
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
204
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (21)

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

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Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium

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