MedDataX Logo

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

NCT ID: NCT00002503

Last Updated: 2012-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

1992-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Cancer Prostate Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

recurrent prostate cancer bone metastases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

strontium chloride Sr 89

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

G. O. N. Oosterhof, MD, PhD

Role: STUDY_CHAIR

Academisch Ziekenhuis Maastricht

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Site Status

Universitair Ziekenhuis Gent

Ghent, , Belgium

Site Status

U.Z. Gasthuisberg

Leuven, , Belgium

Site Status

Aarhus Kommunehospital

Aarhus, , Denmark

Site Status

Rigshospitalet

Copenhagen, , Denmark

Site Status

Ospedale B. Ramazzini

Carpi, , Italy

Site Status

Universita Degli Studi di Firenze - Policlin. di Careggi

Florence, , Italy

Site Status

Instituto Scientifico H.S. Raffaele

Milan, , Italy

Site Status

San Raffaele Hospital

Rome, , Italy

Site Status

Ospedale di Circolo e Fondazione Macchi

Varese, , Italy

Site Status

Groot Ziekengasthuis 's-Hertogenbosch

's-Hertogenbosch, , Netherlands

Site Status

Antoni van Leeuwenhoekhuis

Amsterdam, , Netherlands

Site Status

Academisch Medisch Centrum

Amsterdam, , Netherlands

Site Status

Academisch Ziekenhuis Groningen

Groningen, , Netherlands

Site Status

University Medical Center Nijmegen

Nijmegen, , Netherlands

Site Status

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, , Poland

Site Status

Hospital Santa Maria

Lisbon, , Portugal

Site Status

Medical Radiological Research Center

Obninsk, , Russia

Site Status

Inselspital, Bern

Bern, , Switzerland

Site Status

Newcastle General Hospital

Newcastle upon Tyne, England, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium Denmark Italy Netherlands Poland Portugal Russia Switzerland United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Oosterhof GO, Roberts JT, de Reijke TM, Engelholm SA, Horenblas S, von der Maase H, Neymark N, Debois M, Collette L. Strontium(89) chloride versus palliative local field radiotherapy in patients with hormonal escaped prostate cancer: a phase III study of the European Organisation for Research and Treatment of Cancer, Genitourinary Group. Eur Urol. 2003 Nov;44(5):519-26. doi: 10.1016/s0302-2838(03)00364-6.

Reference Type RESULT
PMID: 14572748 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EORTC-30921

Identifier Type: -

Identifier Source: secondary_id

EORTC-30921

Identifier Type: -

Identifier Source: org_study_id