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 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT02758132
Eligibility Criteria:
Inclusion Criteria:
* Histologic proof of adenocarcinoma of the prostate with clinical evidence of metastatic disease to the bone.
* Castrate resistant progression of prostate carcinoma, as shown by:
* Serum testosterone level \<50 ng/dL or prior bilateral orchiectomy. Treatment to maintain castrate levels of testosterone should continue, and
* Either symptomatic progression, or, if patient is asymptomatic then a rising serum PSA in two occasions at least 1 week apart, with minimum pre-treatment serum PSA of 5 ng/dL.
* Patients with nodal disease are eligible.
* Bi-dimensionally measurable disease within the bone.
* Life expectancy of at least 12 weeks.
* ECOG Performance status \< 2
* Adequate:
* Bone marrow function; absolute neutrophil count \> 1,500 mm3, platelet count of \> 100,000 mm3 and hemoglobin \> 9.0 gm/dl.
* Hepatic function; SGOT/SGPT and conjugated bilirubin less than twice the upper limit of normal.
* Renal function; serum creatinine ≤ 2 mg/dL (or, if creatinine \> 2 mg/dL, then a creatinine clearance of at least 35 ml/min (measured or estimated by the Cockroft formula:
CLcr = \[(140-age) x wt (kg)\]/\[72 x serum creatinine (mg/dL)\].
* No evidence of coagulopathy as indicated by PT \< 1.5X upper limit of normal.
* Serum calcium (corrected) from 8 to11.5 mg/dL (2 to 2.9 mmol/L) - Patients must sign an informed consent indicating that they are aware of the investigational nature of the study.
Exclusion Criteria:
* Patients with variant histologies (e.g., ductal or small cell carcinoma).
* Patients with visceral disease are ineligible.
* Patients who have had prior Sipuleucel-T, docetaxel, cabazitaxel, abiraterone or enzalutamide as a single agent, or in combination therapy.
* Concurrent cancer chemotherapy, radiotherapy or surgery.
* Concurrent serious infection.
* Life threatening illness (e.g., congestive heart failure, uncontrolled angina or myocardial infarction in the prior six months).
* Hypertension uncontrolled by medication.
* Patients who are known to require invasive dental procedures.
* No known or suspected brain metastases (NOTE: patients with treated epidural disease are allowed)
* Administration of any investigational drug within 28 days prior to receipt of denosumab.
* Age ≤ 18 years of age
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02758132
Study Brief:
Protocol Section:
NCT02758132