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 @ 1:36 PM
Ignite Modification Date:
2025-12-24 @ 1:36 PM
NCT ID:
NCT02598895
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial information
* Histologically or cytologically confirmed carcinoma of the prostate (excluding neuroendocrine differentiation or squamous cell histology)
* Ongoing gonadal androgen deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues, antagonists or orchiectomy; patients who have not had an orchiectomy must be maintained on effective GnRH analogue/antagonist therapy
* Castration resistant prostate cancer as defined by rising PSA when serum testosterone \< 50 ng/ml (note: current testosterone results are not required if the potential subject has not missed any GnRH analogue/antagonist doses since their last result was received) AND one of the following:
* PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart
* Evaluable disease progression by modified RECIST (Response Evaluation Criteria in Solid Tumors)
* Progression of metastatic bone disease on bone scan with \> 2 new lesions
* Prior therapy with abiraterone, enzalutamide and/or docetaxel; there is no limit to the number of prior treatment regimens
* Presence of metastatic disease on scans
* Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1
* Life expectancy \>= 12 weeks
* No prior malignancy is allowed except:
* Adequately treated basal cell or squamous cell skin cancer or
* In situ carcinoma of any site or
* Other adequately treated malignancy for which the patient has been disease-free for at least one year (any prior chemotherapy is allowed)
* Absolute neutrophil count \>= 1.5 x 10\^9 cells/L
* Hemoglobin (Hgb) \>= 9.0 g/dL
* Platelets \>= 100,000 x 10\^9/L
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =\< 1.5 x upper limit of normal (ULN)
* Total bilirubin levels =\< 1.5 x ULN
* Patients must have clear and documented evidence of biallelic inactivation BRCA1, BRCA2 or ATM by sequencing, for example University of Washington (UW)-Oncoplex, SU2C, or Foundation One testing and/or patients with clearly deleterious mutations of other genes involved in homologous DNA repair (e.g., partner and localizer of BRCA2 \[PALB2\], BRCA1-interacting protein 1 \[BRIP1\], etc.) by sequencing via UW-Oncoplex, SU2C, or Foundation One testing may be included at the investigator's discretion
Exclusion Criteria:
* Currently receiving active therapy for other neoplastic disorders
* Histologic evidence of neuroendocrine or small cell carcinoma of the prostate
* Known parenchymal brain metastasis
* Active or symptomatic viral hepatitis or chronic liver disease
* Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class II-IV heart disease or cardiac ejection fraction measurement of \< 35 % at baseline, if done
* Treatment with an investigational therapeutic within 30 days of cycle 1
* Patients with dementia/psychiatric illness/social situations limiting compliance with study requirements or understanding and/or giving of informed consent are not eligible
* Any medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained are not eligible
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02598895
Study Brief:
Protocol Section:
NCT02598895