Testing different chemotherapy drugs plus surgery for prostate cancer patients without metastasis
Official title: 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
Run by Shanghai Jiao Tong University School of Medicine · NCT03258320 · Data updated 2026-11-12
This study is testing if giving different chemotherapy drugs before surgery can help men with localized prostate cancer control their tumors better and lower the chances of the cancer getting worse.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 40 Years to 75 Years |
| Sex | Men only |
| Enrollment | 300 (estimated) |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy, bevacizumab, radiation, prednisone |
| Locations | 2 sites (Qingdao, Shandong and 1 other locations) |
| Status | Recruiting |
| Started | January 2015 |
| Main results expected | December 2026 |
| Study ends | December 2027 |
| Registry record updated | January 12, 2026 |
| Trial ID | NCT03258320 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men aged 40 to 75 with histologically confirmed prostate cancer at clinical stage T2c or higher, without distant metastasis.
✕Probably not a fit
Patients over the age of 75, those with severe organ dysfunction, or those who have received prior chemotherapy are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of four chemotherapy agents—Cabazitaxel, Docetaxel, Mitoxantrone, and Satraplatin—administered before surgery in patients with localized prostate cancer. The aim is to determine if neoadjuvant chemotherapy can improve tumor control and reduce the risk of progression to castration-resistant prostate cancer. Participants will be closely monitored for their response to treatment and overall health status. The study includes a randomized approach to compare the outcomes of the different chemotherapy regimens.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for prostate cancer, potentially enhancing survival rates and quality of life for patients.
How similar studies have gone: Other studies have shown promising results with neoadjuvant chemotherapy in prostate cancer, suggesting that this approach may be beneficial, although the specific combinations being tested here may be novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Qilu Hospital of Shandong University
Qingdao, Shandong, China Recruiting -
Zhongshan Hospital
Shanghai, China Recruiting
Study contacts
- Principal investigator: Yu Sun, Ph.D — Shanghai Jiao Tong University School of Medicine
- Study coordinator: Yu Sun, Ph.D
- Email: sunyu@sibs.ac.cn
- Phone: 86-21-54923302
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This program tests whether a focused questionnaire plus quality-of-life screening can detect and help manage side effects in people who have finished curative treatment for breast or prostate cancer.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.