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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT01062503
Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically confirmed prostate cancer that has become castration resistant
* Radiological or pathological evidence of bone metastases. (Positive bone scan, MRI, or CT or pathological fracture, or pathological sample from bone biopsy showing evidence of metastatic prostate cancer)
* Patient has not yet started on BP therapy for metastatic castration resistant prostate cancer
* Renal and hepatic function within the institutional normal range or at the discretion of the Investigator
* Age ≥ 18 years
* ECOG performance status ≤ 2
* Life expectancy \>6 months
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Hypersensitivity or known allergy to bisphosphonates
* Patient who has received BP therapy for any reason within the past 1 year
* Acute or chronic renal insufficiency
* Evidence of infection/abscess on dental exam or recent dental extraction (within last 4 weeks)
* Acute pathological fracture, spinal cord compression, or hypercalcemia requiring urgent treatment (patient may enter study after acute issues are resolved)
* Patients with baseline hypocalcemia
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01062503
Study Brief:
Protocol Section:
NCT01062503