RecruitingPhase 2Phase 3NCT03258320

A Randomised Trial of Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin (CDMS) Plus Surgery for Prostate Cancer Patients

A Phase II-III Study of Neoadjuvant Chemotherapy Involving Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin (CDMS) Followed by Surgery for Patients With High Risk Prostate Cancer

Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

300 participants

Start Date

Jan 1, 2015

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer Patients

Summary

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

Sex: MALEMin Age: 40 YearsMax Age: 75 Years

Inclusion Criteria5

≤ age ≤ 75 years with histologically proven PCa
no severe major organ dysfunction
WHO performance status of 0 or 1
no prior cancer chemotherapy
A Clinical Stage ≥ T2c (T2c, N0, M0) of prostate cancer but ideally without diagnosed distant metastasis (according to the 2016 American Joint Committee on Cancer (AJCC) definition of TNM staging system, Staging Manual, Eighth Edition) as determined by a preoperative evaluation that included a pleural computed tomography (CT) scan.

Exclusion Criteria5

age ≥ 76
severe major organ dysfunction
WHO performance status of \>1
prior cancer chemotherapy
Stage IV.

Interventions

DRUGCabazitaxel, Docetaxel, Mitoxantrone or Satraplatin

As 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.