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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexMale
Age40-75
SponsorShanghai Jiao Tong University School of Medicine

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin

    Drug

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: CDMS, SurgeryExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

5 years disease-free survival

There is no disease-associated progression during the 5 years post treatment (chemotherapy plus surgery).

Time frame
5 years

Secondary outcomes

1

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).

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Jiao Tong University School of Medicine

Lead sponsor

Fudan University

Collaborator

Qilu Hospital of Shandong University

Collaborator