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.

Condition	Treatment or Intervention	Phase
bone metastases recurrent prostate cancer	Drug: strontium chloride Sr 89	Phase III

Further Study 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.

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

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

Study chairs or principal investigators

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

Study ID Numbers:  CDR0000077931; EORTC-30921
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002503
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08