About this trial
Current agents administered in therapeutic regimens of prostate cancer employ different mechanisms to eliminate neoplastic cells by inducing substantial apoptosis and causing tumor regression. Treatment with neoadjuvant chemotherapy before radical prostatectomy may better control the tumor before it has the chance to convert into the disease of castration-resistant prostate cancer (CRPC), which is finally refractory to most modalities of clinical intervention with a clinically lethal nature.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
40 ≤ age ≤ 75 years with histologically proven PCa
no severe major organ dysfunction
WHO performance status of 0 or 1
no prior cancer chemotherapy
Disqualifiers
age ≥ 76
severe major organ dysfunction
WHO performance status of >1
prior cancer chemotherapy
Trial design
Parallel
Treatments tested in this trial
Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin
DrugAs preoperative neoadjuvant chemotherapy, drugss including Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin (CDMS) will be administered as a single agent performed 45 days before surgery:Cabazitaxel 25 mg/m2, Docetaxel 35 mg/m2, Mitoxantrone 4 mg/m2 or Satraplatin 80 mg/m2, through intravenous (IV) or oral (Satraplatin) administration. IV or oral administration once every 7 days, totally 4 cycles. There is a 17-day interval between the last dose and surgery.
Treatment groups
Trial outcomes
Primary outcomes
5 years disease-free survival
There is no disease-associated progression during the 5 years post treatment (chemotherapy plus surgery).
Secondary outcomes
5 years overall survival and metastasis-free survival
The overall survival status and distant metastasis-free survival status during the 5 years post treatment (chemotherapy plus surgery).
Sponsors and contacts
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Shanghai Jiao Tong University School of Medicine
Lead sponsor
Fudan University
Collaborator
Qilu Hospital of Shandong University
Collaborator