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 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT02560051
Eligibility Criteria:
Inclusion criteria:
* Pathologic proof of adenocarcinoma of the prostate.
* Patients must belong to one of the following subsets:
* Prior local therapy
* Patients with Prostate Specific Antigen (PSA) recurrence following prostatectomy or radiation therapy who have no radiographic involvement. PSA doubling time ≤6 months.
* Nodal involvement only.
* Low volume bone disease: ≤3 metastases.
* Nodal involvement with associated bone involvement.
* High volume bone-visceral disease: Patients with \>3 metastatic bone sites or visceral metastases.
* No prior definitive local therapy
* Tumors felt to be unresectable, not candidates for radiation therapy, and PSA elevated with biopsy-proven disease.
* Metastatic disease at presentation.
* Patients may have started ADT within 3 months of study entry.
* No previous cytotoxic therapy is allowed, including systemic irradiation with strontium-89, samarium, or radium-223.
* Previous definitive radiotherapy to one metastatic site is acceptable, provided that unirradiated sites remain. At least 8 weeks must have elapsed since radiation therapy to the pelvis. Patients having limited irradiation of a metastatic site are eligible 4 weeks following radiation.
* Patients may have had previous exposure to ADT if it was given for ≤6 months to "downstage" the primary and provided that such therapy was completed at least 12 months prior to entry into this study with a return of serum testosterone to ≥200 ng/dL.
* Patients must be free of serious comorbidity and have a life expectancy of ≥3 years.
* Patients must have adequate physiologic reserves as evidenced by:
* Eastern Cooperative Oncology Group (ECOG) status of ≤2.
* Patients must have adequate bone marrow function: Platelets ≥100,000 cells/mm3, Hemoglobin ≥9.0 g/dL, and Absolute Neutrophil Count (ANC) ≥1,500 cells/mm3.
* Patients must have adequate renal function: creatinine ≤2 × upper limit of normal (ULN).
* Patients must have adequate liver function: Aspartate aminotransferase (AST) / Alanine transaminase (ALT) ≤2.5 × ULN; alkaline phosphatase \<2.5 × ULN, unless bone metastasis is present in the absence of liver metastasis; and bilirubin \< ULN or 1.5 mg/dl.
* No evidence of active ischemia on electrocardiogram (ECG) and documentation of ejection fraction (EF) ≥50%.
Exclusion criteria:
* Patients must not have a second malignancy unless there is confidence of previous curative therapy.
* Patients with a recent history of transient ischemic attack (TIA) (within 6 months), who are requiring regular antianginal therapy, or who are having claudication sufficient to limit activity are not eligible. Patients with a previous history of deep venous thrombosis or pulmonary embolism (within 12 months) are not eligible
* Patients must not have a serious intercurrent medical or psychiatric illness, including serious active infection.
* Patients must not have sensory neuropathy \> grade 1.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02560051
Study Brief:
Protocol Section:
NCT02560051