Prostate Cancer
Conditions
Interventions
Case series:neoadjuvant ADT combined with docetaxel + cisplatin chemotherapy
Sponsors
Renji Hospital, Affiliated to Shanghai Jiao Tong University, School of Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 75 years male; (2) Histology or cytology diagnosis: Prostate adenocarcinoma; (3) ECOG performance Status =10 years; (4) Without clinical or radiographic metastases in 6 months (Bone scan, MRI or pelvic enhanced CT scan, PET-CT) ; (5) The patients of locally advanced prostate cancer need to satisfy at least one of the following requirements: clinical stageT3a-T4, N0, M0; any T, N1, M0; (6) Systemic or germline DNA repair defects were confirmed by blood or histological second-generation sequencing (NGS); (7) Without radiographic treatment towards primary tumour; (8) Without opioids (including codeine and dextropropoxyphene) relieving relevant pain of cancer; (9) Without azole drugs (such as fluconazole, itraconazole); (10) Important laboratory indicators are as follows: aHaemoglobin >=90g/L; bANC >=1500/uL; cPLT>=100*10^9/L; dK+ >=3.5mmol/L; eAST or ALT =30g/L; gcalculated Ccr>60 ml/min, serum creatinine <=ULN; (11) Without swallowing disease, able to swallow the whole piece of drugs; (12) Without other tumour chemotherapy history, without chemotherapy and endocrine therapy contraindications; (13) If patients spouse is at her childbearing age, the patient needs to agree that effective contraception should be taken during the treatment and 4 months after the operation; (14) Subjects volunteer to participate, the subject must sign an informed consent form (ICF), indicating the understanding of the purpose and the required procedures of the study, and willing to participate in the study. Subjects must be willing to comply with the prohibitions and restrictions set forth in the program.
Exclusion criteria
Exclusion criteria: (1) The pathology result of prostate is neuroendocrine prostate cancer, including small cell carcinoma; (2) Previous cytotoxic chemotherapy or biological therapy for prostate cancer; (3) Contraindications to prednisone, such as active infections or other disorders; (4) Patients with chronic disease needed to be given dose of prednisone (each time 5mg, bid a day) exceed the dose in the study; (5) High blood pressure with poor control of drugs (systolic blood pressure >=160 mmHg or diastolic blood pressure >=95 mmHg); (6) Active or symptomatic viral hepatitis or other chronic liver disease, known infected with human immunodeficiency virus (HIV); (7) A disease history of pituitary or adrenal dysfunction; (8) Patients with active autoimmune disease who need hormone therapy; (9) Heart disease with clinical significance, including: myocardial infarction or arterial thrombosis occurred in the past 6 months; severe or unstable angina; New York Heart Association grade III or IV heart disease (Appendix 4); atrial fibrillation or other arrhythmias that require treatment; (10) Subjects who participated in other clinical studies within a month before the first use of chemotherapy; (the elution time is at least 5 times the half-life time of the study drug if the half-life time is too long.); (11) Patients with a history of hypersensitivity to Taxanes or docetaxel; (12) Other circumstances considered inappropriate by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological remission rate;adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Biochemical progression-free survival; | — |
Countries
China
Contacts
Public ContactWei Xue
Renji Hospital, Affiliated to Shanghai Jiao Tong University, School of Medicine
Outcome results
None listed