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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT02814669
Eligibility Criteria:
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy greater than or equal to (\>/=) 12 weeks
* Histologically confirmed, castrate-resistant adenocarcinoma of the prostate
* Measurable disease according to RECIST v1.1
* Multiple bone metastases within 12 weeks prior to study drug
* Participants receiving bisphosphonate or denosumab therapy must have been on a stable dose for at least 4 weeks
* Visceral metastasis and/or lymphadenopathy
* Tumors that are amenable to serial biopsy
* Disease progression according to Prostate Cancer Working Group 2 (PCWG2) criteria during or following treatment with at least one second generation androgen pathway inhibitor (for example, enzalutamide, abiraterone) for metastatic prostate cancer
* Adequate hematologic and end-organ function
* One prior taxane-containing regimen for mCRPC, or refusal or ineligibility of a taxane-containing regimen
Exclusion Criteria:
* History of small-cell or neuroendocrine prostate carcinoma
* Treatment with approved anti-cancer therapy (with the exception of abiraterone) within 3 weeks of study drug. Abiraterone must not be administered within 2 weeks prior to initiation of study treatment
* Participation in another clinical trial/investigation within 28 days prior to study drug
* Brain metastases or active leptomeningeal disease (with the exception of participants with treated epidural disease and no other epidural progression)
* Uncontrolled tumor-related pain
* Uncontrolled hypercalcemia
* Significant cardiovascular disease
* History of autoimmune disease except controlled/treated hypothyroidism, type 1 diabetes mellitus, or certain skin disorders
* Prior allogeneic stem cell or solid organ transplant
* History of pulmonary fibrosis/inflammation, including active tuberculosis
* Human immunodeficiency virus (HIV) or hepatitis B or C
* Prior treatment with cluster of differentiation (CD) 137 agonist, anti-programmed death (PD) 1, or anti-programmed death ligand (PD-L) 1 therapeutic antibody or pathway-targeting agents
* Immunostimulants within 4 weeks or immunosuppressants within 14 days prior to study drug
* Prior radium-223 dichloride or hemibody external radiotherapy
* Systemic strontium-89, samarium-153, rhenium-186, or rhenium-188 for bone metastases within 24 weeks prior to initiation of study treatment
* Spinal compression or structurally unstable bone lesions suggesting impending pathologic fractures based on clinical findings and/or magnetic resonance imaging (MRI)
* Bone marrow dysplasia
* Unmanageable fecal incontinence
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02814669
Study Brief:
Protocol Section:
NCT02814669