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



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

For Condition: bone metastases,recurrent prostate cancer
Status: No longer recruiting
Sponsor(s): EORTC Genito-Urinary Tract Cancer Cooperative Group ,
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
G.O.N.Oosterhof,  Study Chair,  EORTC Genito-Urinary Tract Cancer Cooperative Group

Hospital Santa Maria
Lisbon,  ,  1699
Portugal
 

San Raffaele Hospital
Rome,  ,  00144
Italy
 

Universita Degli Studi di Firenze - Policlin. di Careggi
Florence,  ,  1 (50-134)
Italy
 

U.Z. Gasthuisberg
Leuven,  ,  B-3000
Belgium
 

Inselspital, Bern
Bern,  ,  CH-3010
Switzerland
 

Ospedale di Circolo e Fondazione Macchi
Varese,  ,  21100
Italy
 

Newcastle General Hospital
Newcastle upon Tyne,  England,  NE4 6BE
United Kingdom
 

Universitair Ziekenhuis Gent
Ghent,  ,  B-9000
Belgium
 

Universitair Ziekenhuis Antwerpen
Edegem,  ,  B-2650
Belgium
 

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw,  ,  02-781
Poland
 

Medical Radiological Research Center
Obninsk,  , 
Russian Federation
 

Academisch Medisch Centrum
Amsterdam,  ,  1105 AZ
Netherlands
 

Rigshospitalet
Copenhagen,  ,  2100
Denmark
 

Ospedale B. Ramazzini
Carpi,  ,  41012
Italy
 

Groot Ziekengasthuis 's-Hertogenbosch
's-Hertogenbosch,  ,  5211 NL
Netherlands
 

Academisch Ziekenhuis Groningen
Groningen,  ,  9713 EZ
Netherlands
 

Antoni van Leeuwenhoekhuis
Amsterdam,  ,  1066 CX
Netherlands
 

Cliniques Universitaires Saint-Luc
Brussels,  ,  1200
Belgium
 

Instituto Scientifico H.S. Raffaele
Milan,  ,  20132
Italy
 

University Medical Center Nijmegen
Nijmegen,  ,  NL-6252 HB
Netherlands
 

Aarhus Kommunehospital
Aarhus,  ,  DK-8000
Denmark
 


Additional Information:
Study ID Numbers:
  CDR0000077931;  EORTC-30921
Study Start Date: October 1992
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002503

Other Recurrent Prostate Cancer Studies:
1. Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid Tumors

2. Hormone Therapy With or Without Mitoxantrone and Prednisone in Treating Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer

3. Chemotherapy in Treating Patients With Prostate Cancer

4. Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

5. Brachytherapy in Treating Patients With Recurrent Prostate Cancer

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