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 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
NCT ID:
NCT02814968
Eligibility Criteria:
Inclusion Criteria:
* Male aged 18 years or older;
* Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features;
* Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy;
* Three consecutive rises of PSA, 1 week apart, resulting in two 50% increases over the nadir, with PSA of at least \> 5 ng/mL but preferably \>10 ng/mL;
* Progressive disease as defined by rising PSA levels plus by evidence of progressive and measurable soft tissue or bone disease by 18F-FDG PET/CT, Whole Body MRI or both;
* Castrate serum levels of testosterone \< 50 ng/dL or \< 1.7 nmol/L;
* Anti-androgen withdrawal for at least 6 weeks for bicalutamide, nilutamide or flutamide for at least 6 weeks;
* No prior treatment with cytotoxic chemotherapy;
* Eastern Cooperative Oncology Group (ECOG) score 0-2;
* A life expectancy of at least 12 months;
* Written informed consent.
Exclusion Criteria:
* Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrolment;
* Known or suspected brain metastasis or active leptomeningeal disease;
* History of another malignancy within the previous 5 years other than curatively treated non melanomatous skin cancer;
* Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 times the upper limit of normal at the Screening visit;
* Creatinine \> 177 µmol/L (2 mg/dL) at the Screening visit;
* Hemoglobin \<6 mmol/L, White blood cells \< 4.0 x10\^9/L, platelets \< 100 x 10\^9/L;
* History of seizure or any condition that may predispose to seizure. Also, history of loss of consciousness or transient ischemic attack within 12 months of enrolment (Day 1 visit);
* Contra-indication for MRI (e.g. pacemaker).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02814968
Study Brief:
Protocol Section:
NCT02814968