Actively Recruiting
A Phase II-III Study of Neoadjuvant Chemotherapy Followed by Surgery for Patients With High Risk Prostate Cancer Using Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2026-01-12
300
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Shanghai Jiao Tong University School of Medicine
Lead Sponsor
F
Fudan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Prostate cancer is a disease where harmful cells grow in the prostate gland, affecting mainly men aged 40 to 75 years in this study. Researchers are exploring whether giving chemotherapy before surgery can better control high-risk prostate cancer and prevent it from becoming resistant to hormone therapy, which is harder to treat. This trial is a Phase II-III randomized study to evaluate chemotherapy agents given before surgery compared to surgery alone in men with localized prostate cancer. Participants receive one of four chemotherapy drugs—Cabazitaxel, Docetaxel, Mitoxantrone, or Satraplatin—administered as a single agent 45 days before surgery. The chemotherapy is given either intravenously or orally once a week for four weeks, with a 17-day break before the radical prostatectomy surgery. Another group undergoes surgery without any prior chemotherapy, allowing comparison of outcomes between the two approaches. During the study, men will be monitored closely with clinical assessments and imaging to evaluate their health and cancer status. Researchers will measure how long participants remain free of disease over five years, as well as overall survival and metastasis-free survival. The study also examines the impact of chemotherapy on tumor tissue and how it might affect cancer progression. Participation lasts at least five years to carefully track these long-term outcomes.
CONDITIONS
Brief Title
A Randomised Trial of Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin (CDMS) Plus Surgery for Prostate Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 40 to 75 years with prostate cancer confirmed by tissue biopsy
- No severe major organ dysfunction
- WHO performance status of 0 or 1
- No prior chemotherapy for cancer
- Clinical stage T2c or higher (T2c, N0, M0) without distant metastasis as confirmed by preoperative CT scan
You will not qualify if you...
- Age 76 years or older
- Severe major organ dysfunction
- WHO performance status greater than 1
- Prior chemotherapy for cancer
- Stage IV prostate cancer
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 28 days
Participants receive preoperative chemotherapy with one of the drugs Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin administered once every 7 days for 4 cycles.
4 weekly visits (in-person) for chemotherapy administration
Duration - Surgery day plus immediate recovery period
Participants undergo radical prostatectomy surgery approximately 17 days after the last chemotherapy dose or directly if assigned to surgery only without chemotherapy.
1 visit (in-person) for surgery
Trial Site Locations
Total: 2 locations
1
Qilu Hospital of Shandong University
Qingdao, Shandong, China, 266035
Actively Recruiting
2
Zhongshan Hospital
Shanghai, China, 200032
Actively Recruiting
Research Team
Y
Yu Sun, Ph.D
W
Weijun Ma, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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