Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer Patients | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CDMS, Surgery
- description
- Preoperative chemotherapy using Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin (CDMS) 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. Procedure: radical prostatectomy surgery.
- interventionNames
- Drug: Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin
- type
- NO_INTERVENTION
- label
- Control
- description
- No neoadjuvant chemotherapy using CDMS will be done for patients who are diagnosed with localized prostate cancer but subject to direct surgery to radically remove the primary tumor.
Primary outcomes (1)
- measure
- 5 years disease-free survival
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available