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

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving chemotherapy before or around the time of prostate surgery (radical prostatectomy) improves outcomes compared to surgery alone in men with intermediate to high-risk localized prostate cancer. **You may be eligible if...** - You are between 40 and 75 years old - You have been confirmed (by biopsy) to have prostate cancer - You have not had any previous cancer chemotherapy - You have a reasonably good performance status (able to carry out daily activities) - Your prostate cancer is at least Stage T2c (a significant but locally contained tumor) **You may NOT be eligible if...** - You are 76 or older - You have severe problems with major organs (heart, liver, kidneys, etc.) - You have already had chemotherapy for any cancer - Your cancer has spread to distant parts of the body (Stage IV) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.