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Clinical Trials in China / NCT03258320
Recruiting Phase 2/3

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

NCT03258320 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Jiao Tong University School of Medicine
Phase
Phase 2/3
Started
2015-01
Last updated
2026-01-12

Condition(s) studied

Prostate Cancer Patients

Investigational drug(s) / intervention(s)

Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin

Cabazitaxel, 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.

Study 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
MALE
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 40 ≤ 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 Criteria: * age ≥ 76 * severe major organ dysfunction * WHO performance status of \>1 * prior cancer chemotherapy * Stage IV.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Qilu Hospital of Shandong University Qingdao Shandong Recruiting
Zhongshan Hospital Shanghai China Recruiting

More Shanghai Jiao Tong University School of Medicine trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03258320 on ClinicalTrials.gov ↗ ← All trials in China