A Randomised Trial of Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin (CDMS) Plus Surgery for Prostate Cancer Patients Without Metastasis

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborators: Fudan University; Qilu Hospital of Shandong University
• Treatments: Docetaxel; Mitoxantrone; Satraplatin

Criteria

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 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.