Testing different chemotherapy drugs plus surgery for prostate cancer patients without metastasis
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
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 |
| Enrollment | 300 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | Male |
| 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) |
| Trial ID | NCT03258320 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men aged 40 to 75 with histologically confirmed prostate cancer at clinical stage T2c or higher, without distant metastasis.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Qingdao, Shandong and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.