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.

Study Timeline

• Study Start: 1992-10
• Study First Submitted: 1999-11-01
• Primary Completion: 2000-11
• Study First Submitted QC: 2004-05-19
• Study First Posted: 2004-05-20
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-20
• Last Update Posted: 2012-09-24

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

Trial Locations

Locations (21)

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Academisch Ziekenhuis Groningen; 🇳🇱 Groningen, Netherlands

Medical Radiological Research Center; 🇷🇺 Obninsk, Russian Federation

Universitair Ziekenhuis Gent; 🇧🇪 Ghent, Belgium

University Medical Center Nijmegen; 🇳🇱 Nijmegen, Netherlands

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology; 🇵🇱 Warsaw, Poland

Inselspital, Bern; 🇨🇭 Bern, Switzerland

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, 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

Groot Ziekengasthuis 's-Hertogenbosch; 🇳🇱 's-Hertogenbosch, Netherlands

Ospedale di Circolo e Fondazione Macchi; 🇮🇹 Varese, Italy

Hospital Santa Maria; 🇵🇹 Lisbon, Portugal

Antoni van Leeuwenhoekhuis; 🇳🇱 Amsterdam, Netherlands

Newcastle General Hospital; 🇬🇧 Newcastle Upon Tyne, England, United Kingdom