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

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

February 6, 2009

Start Date ^ICMJE

October 1992

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00002503 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Metastatic Cancer
Prostate Cancer

Intervention ^ICMJE

Radiation: strontium chloride Sr 89

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, Denmark, Italy, Netherlands, Poland, Portugal, Russian Federation, Switzerland, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00002503

Responsible Party

Study ID Numbers ^ICMJE

CDR0000077931, EORTC-30921

Study Sponsor ^ICMJE

European Organization for Research and Treatment of Cancer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

G. O. N. Oosterhof, MD, PhD

Academisch Ziekenhuis Maastricht

Information Provided By

National Cancer Institute (NCI)

Verification Date

February 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP