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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002503 |
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 | Intervention | Phase |
---|---|---|
Metastatic Cancer Prostate Cancer |
Drug: strontium chloride Sr 89 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A PROSPECTIVE MULTICENTER RANDOMIZED STUDY COMPARING STRONTIUM-89 CHLORIDE AND PALLIATIVE LOCAL FIELD RADIOTHERAPY IN PATIENTS WITH HORMONAL ESCAPED ADVANCED PROSTATIC CANCER |
Study Start Date: | October 1992 |
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.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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
Belgium | |
Cliniques Universitaires Saint-Luc | |
Brussels, Belgium, 1200 | |
U.Z. Gasthuisberg | |
Leuven, Belgium, B-3000 | |
Universitair Ziekenhuis Antwerpen | |
Edegem, Belgium, B-2650 | |
Universitair Ziekenhuis Gent | |
Ghent, Belgium, B-9000 | |
Denmark | |
Aarhus Kommunehospital | |
Aarhus, Denmark, DK-8000 | |
Rigshospitalet | |
Copenhagen, Denmark, 2100 | |
Italy | |
Instituto Scientifico H.S. Raffaele | |
Milan, Italy, 20132 | |
Ospedale B. Ramazzini | |
Carpi, Italy, 41012 | |
Ospedale di Circolo e Fondazione Macchi | |
Varese, Italy, 21100 | |
San Raffaele Hospital | |
Rome, Italy, 00144 | |
Universita Degli Studi di Firenze - Policlin. di Careggi | |
Florence, Italy, 1 (50-134) | |
Netherlands | |
Academisch Medisch Centrum | |
Amsterdam, Netherlands, 1105 AZ | |
Academisch Ziekenhuis Groningen | |
Groningen, Netherlands, 9713 EZ | |
Antoni van Leeuwenhoekhuis | |
Amsterdam, Netherlands, 1066 CX | |
Groot Ziekengasthuis 's-Hertogenbosch | |
's-Hertogenbosch, Netherlands, 5211 NL | |
University Medical Center Nijmegen | |
Nijmegen, Netherlands, NL-6252 HB | |
Poland | |
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | |
Warsaw, Poland, 02-781 | |
Portugal | |
Hospital Santa Maria | |
Lisbon, Portugal, 1699 | |
Russian Federation | |
Medical Radiological Research Center | |
Obninsk, Russian Federation | |
Switzerland | |
Inselspital, Bern | |
Bern, Switzerland, CH-3010 | |
United Kingdom, England | |
Newcastle General Hospital | |
Newcastle Upon Tyne, England, United Kingdom, NE4 6BE |
Study Chair: | G. O. N. Oosterhof, MD, PhD | Academisch Ziekenhuis Maastricht |
Study ID Numbers: | CDR0000077931, EORTC-30921 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002503 |
Health Authority: | United States: Federal Government |
recurrent prostate cancer bone metastases |
Prostatic Diseases Genital Neoplasms, Male Neoplasm Metastasis Urogenital Neoplasms |
Pain Genital Diseases, Male Prostatic Neoplasms Recurrence |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes |