Neoadjuvant Chemo-hormonal Therapy Combined With Radical Prostatectomy for Locally Advanced Prostate Cancer

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

To evaluate of the value of radical prostatectomy and extended pelvic lymph node dissection in locally advanced prostate cancer after neoadjuvant hormonal therapy with or without docetaxel chemotherapy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RenJi Hospital
• Treatments: Hormones

Criteria

Inclusion Criteria:

1. 18≤ Aged <75 years, male;

2. Histology or cytology diagnosis: Prostate adenocarcinoma;

3. ECOG performance Status ≤1; Expected lifetime ≥10 years;

4. Without clinical or radiographic metastases in 6 months (Bone scan, MRI or pelvic enhanced CT scan, PET-CT) before randomized;

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. Without Androgen Blockade Treatment in 4 weeks before randomized;

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:

1. Haemoglobin ≥90g/L

2. ANC ≥ 1500/μL

3. PLT≥100*10^9/L

4. K+≥3.5mmol/L

5. AST or ALT ≤1.5 times upper limit of normal (ULN), TBIL should be ≤ULN (except patients with certified Gilbert syndrome) and ALP≤5ULN

6. ALB≥30g / L

7. calculated 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 patient's 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:

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 ≥160mmHg or diastolic blood pressure ≥95mmHg);

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. Patients who are concomitantly receiving strong CYP3A4 inhibitors

13. Other circumstances considered inappropriate by investigator.