Phase
Condition
Prostate Cancer
Prostate Cancer, Early, Recurrent
Urologic Cancer
Treatment
N/AClinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient can provide detailed clinical baseline information including: name, age,gender, pathology, past treatment, etc.;
Male, age ≥ 18 years old;
ECOG score 0~2 points;
Patient must be able to provide tissue samples for the drug sensitive test;
No treatment history with PI3K inhibitors, AKT inhibitors or mTOR inhibitors;
Estimated lifetime is ≥ 3 months;
Histological or cytologically determined prostate adenocarcinoma, excludingneuroendocrine differentiation, signet ring cell carcinoma and small cell carcinoma;
Patient is at a castration level and the testosterone level is lower than <50 ng/dL or 1.7 nmol/L;
Received abiraterone or enzalutamide and other new second-generation anti-androgenicdrugs and have disease progression. Disease progression is defined by PCWG3 :Theprogression of disease in PCWG3 is defined as satisfying one of the following:according to the increase in PSA levels, there must be three consecutive increases inPSA at least one week apart, and the minimum value is greater than or equal to 5.0ng/ml; disease progression as assessed by RECIST 1.1, considering PSA levels or not;PCWG3 defines bone disease progression, which is bone scan found 2 or more newlesions;
Evidence of distant metastatic disease (such as bone scans and CT/MRI results),imaging data that can be used to assess the condition before and after treatment, orimaging experience provided by three imaging hospitals with experience in threehospitals. Test reports and oncology indicators include PSA values;
The patient can tolerate the primary physician to perform the puncture operation,after receiving the informed consent from the patient and the family members;
The follow-up period must be at least greater than 2 months;
Be able to follow the research and follow-up procedures to provide real and effectiveinformation;
The patient or his legal guardian understands the test procedure and content andvoluntarily signs the printed informed consent form.
Exclusion
Exclusion Criteria:
Cognitive ability and psychological abnormalities
ECOG score 3-4 points or blood biochemical examination indicates that the patient isnot suitable for continuing chemotherapy or chemotherapy has been postponed
Can not provide enough tumor puncture tissue, not enough tumor cells for subsequentexperiments;
Patient who is unwilling to receive follow-up treatment after the Mini PDX model drugsensitivity test;
The investigator believes that the subject may not be able to complete the study ormay not be able to comply with the requirements of this study (for administrativereasons or other reasons).
Study Design
Study Description
Connect with a study center
Tianjin Medical University Second Hospital
Tianjin, Tianjin 300211
ChinaActive - Recruiting
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