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:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT00216060
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the prostate with metastatic bone disease (by CT, MRI or bone scan) with plans to start or be \< 30 days from beginning androgen deprivation therapy. Patients with lymph node or visceral metastases only are not eligible
* Patients may receive palliative radiation therapy at the investigators discretion during the first 4 weeks of beginning protocol therapy.
Exclusion Criteria:
* No neuroendocrine, small cell or transitional cell cancer of the prostate No abnormal bone metabolism (i.e., Paget's disease, untreated hyperthyroidism, untreated hyperprolactinemia, untreated Cushing's disease).
* No use of calcitonin within 14 days before being registered for protocol therapy or any previous use of bisphosphonates.
* No major surgery within 4 weeks of registration to protocol therapy.
* No adjuvant chemotherapy within 6 months of registration to protocol therapy.
* No previous chemotherapy for metastatic disease.
* No hormonal therapy in the adjuvant setting within 12 months of registration to protocol therapy; previous hormonal therapy must not have exceeded 6 months.
* No prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin.
* No history of allergy or drug reactions to bisphosphonates.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00216060
Study Brief:
Protocol Section:
NCT00216060