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

September 20, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

A PROSPECTIVE MULTICENTER RANDOMIZED STUDY COMPARING STRONTIUM-89 CHLORIDE AND PALLIATIVE LOCAL FIELD RADIOTHERAPY IN PATIENTS WITH HORMONAL ESCAPED ADVANCED PROSTATIC CANCER

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

204

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-luc
      • Edegem, Belgium, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Ghent, Belgium, B-9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
  • Denmark
      • Aarhus, Denmark, DK-8000
        • Aarhus Kommunehospital
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
  • Italy
      • Carpi, Italy, 41012
        • Ospedale B. Ramazzini
      • Florence, Italy, 1 (50-134)
        • Universita Degli Studi di Firenze - Policlin. di Careggi
      • Milan, Italy, 20132
        • Instituto Scientifico H.S. Raffaele
      • Rome, Italy, 00144
        • San Raffaele Hospital
      • Varese, Italy, 21100
        • Ospedale di Circolo e Fondazione Macchi
  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5211 NL
        • Groot Ziekengasthuis 's-Hertogenbosch
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum
      • Amsterdam, Netherlands, 1066 CX
        • Antoni van Leeuwenhoekhuis
      • Groningen, Netherlands, 9713 EZ
        • Academisch Ziekenhuis Groningen
      • Nijmegen, Netherlands, NL-6252 HB
        • University Medical Center Nijmegen
  • Poland
      • Warsaw, Poland, 02-781
        • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
  • Portugal
      • Lisbon, Portugal, 1699
        • Hospital Santa Maria
  • Russian Federation
      • Obninsk, Russian Federation
        • Medical Radiological Research Center
  • Switzerland
      • Bern, Switzerland, CH-3010
        • Inselspital, Bern
  • United Kingdom
    • England
      • Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
        • Newcastle General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS: Histologically or cytologically proven carcinoma of the prostate that has relapsed subsequent to chemical or surgical castration and/or antiandrogen therapy Painful, unirradiated osseous metastasis required Documentation by bone scan and x-ray required Number and extent of metastases determined according to Soloway and fitting grades 1-3 Prior hormonal therapy must have lasted at least 3 months and must be continued until completion of this study No imminent paraplegia related to metastases No uncorrectable urinary incontinence

PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Hematopoietic: WBC greater than 3,500 Platelets greater than 150,000 Hepatic: Not specified Renal: Creatinine no greater than 2.2 mg/dl (200 micromoles/liter) Other: No calcium supplementation No second malignancy except basal cell skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No restriction Endocrine therapy: Prior and concurrent hormonal therapy required Radiotherapy: No prior strontium-89 No prior hemibody or total-body irradiation Prior local-field irradiation for bone metastases allowed provided new site of painful metastases exists Surgery: Surgical castration allowed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: G. O. N. Oosterhof, MD, PhD, Academisch Ziekenhuis Maastricht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1992

Primary Completion (Actual)

November 1, 2000

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

May 19, 2004

First Posted (Estimate)

May 20, 2004

Study Record Updates

Last Update Posted (Estimate)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-30921

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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