Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT00002503
Eligibility 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
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT00002503
Study Brief:
Protocol Section:
NCT00002503