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
About This Trial
- This clinical study is testing whether receiving chemotherapy drugs before having surgery to remove the prostate can better control the cancer and prevent it from returning.
- It is designed for adults aged 40 to 75 who have prostate cancer that has not spread to other parts of the body.
- To qualify, you must be in generally good overall health and must not have received chemotherapy in the past.
- If you consider joining, you should know that you will receive a course of chemotherapy first, followed by planned surgery to remove the prostate.
More Information
- 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.
Who Can Enroll
- Age Range: 40 - 75 years
- Gender: Male
- Who This Trial is For: This clinical study is testing whether receiving chemotherapy drugs before having surgery to remove the prostate can better control the cancer and prevent it from returning.
Study Details
- Start Date: January 2015
- Lead Sponsor: Shanghai Jiao Tong University School of Medicine
Full Eligibility 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 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.
Treatments
- Drug: Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin