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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT00699751
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Known hormone refractory disease
* Multiple skeletal metastases (≥ 2 hot spots) on bone scintigraphy
* No intention to use cytotoxic chemotherapy within the next 6 months
* Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with EBRT (External Beam Radiation Therapy) for bone pain
Exclusion Criteria:
* Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period
* Eligible for first course of docetaxel, i.e. patients who are fit enough, willing and where docetaxel is available
* Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks ago
* Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks
* Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
* History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic CT or chest x-ray within previous 8 weeks
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00699751
Study Brief:
Protocol Section:
NCT00699751