castration-resistant prostate cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: a) Patients who can provide the baseline information in detail: name, age, gender, pathology and previous treatment, etc. b) Men over the age of 18 years c) ECOG score of 0-2 d) Patients who can provide samples to drug sensitivity tests; e) Life expectancy of =3 months; f) Histologically or cytologically confirmed adenocarcinoma of the prostate, excluding neuroendocrine differentiated, signet-ring cell, and small-cell carcinoma; g) Patients after surgical castration, with testosterone values < 50 ng/dL or 1.7 nmol/L; h) Disease progression (as defined by PCWG2) despite previous treatment with abiraterone and enzalutamide or second-generation ADT (Androgen-Deprivation Therapy). Disease progression defined by PCWG2 as meeting any of the following criteria: according to the rise in PSA values, at least 3 consecutive rises in PSA values at a minimum of 1-week intervals, and a baseline PSA value = 5.0 ng/ml; PSA values can be ignored as disease progression assessed by RECIST 1.1; PCWG2-defined bone metastases, i.e. = 2 new lesions presented by bone scan; i) Documented distant metastasis (based on ECT and CT/MRI), providing imaging data for disease evaluation before and after treatment, or a test report for disease evaluation provided by an experienced radiologist from Grade-A tertiary hospital, or tumor markers including PSA value; j) Patients who can tolerate with needle biopsy evaluated by physician in charge; and the biopsy is accepted by patients and their families; k) Follow-up =2 months; l) Patients who can provide true and effective information during the study and the follow-up; m) Patients or whose statutory guardian know the study process and content, with signed informed consent freely and voluntarily.
Exclusion criteria
Exclusion criteria: n) Patients with cognitive or psychological problems; o) ECOG score of 3-4 or blood biochemistry tests indicated to cease or delay chemotherapy; p) Patients who cannot provide sufficient tumor tissues or tumor cells for the study; q) Patients who are thought cannot finish the study or comply with the requirements of the study (for management or other reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survival; | — |
Countries
China
Contacts
North China University of Science and Technology Affiliated Hospital