A Phase 2/3 interventional study of Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin in Prostate Cancer Patients, sponsored by Shanghai Jiao Tong University School of Medicine. Recruiting at 2 sites in China. Open to male participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 2/3, Interventional, and Treatment
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.
Prostate cancer is the development of neoplasia in the prostate, a major gland in the male reproductive system. While most prostate cancers grow slowly, some can develop relatively quickly and aggressively. In a later stage of the disease, cancer cells may disseminate from the prostate to other organs of the body, particularly the bone, lung, brain and lymph node. Prostate cancer initially cause no symptoms, but in an advanced stage it can cause difficulty in urinating, blood in the urine, or pain in the pelvis. A non-malignant or precursor form of prostate cancer known as benign prostatic hyperplasia may produce similar symptoms, although it is essentially not invasive.
Many prostate cancer patients can be safely followed with active surveillance or watchful actions. However, the major forms of clinical treatments include a combination of surgery, radiation, hormone therapy or chemotherapy. If it only occurs inside the prostate, the disease is generally curable. However, when cancer cells have spread to the bones, cytotoxic or harsh therapies are necessary. Outcomes depend on a person's age and other health conditions as well as how aggressive and extensive the cancer is. Most people with prostate cancer do not end up dying from the disease, and the 5-year survival rate in the United States is approximately 99%. To date, it is the 2nd most common type of malignancy and the 5th leading cause of cancer-related death in men. In 2012 it affected 1.1 million men and claimed 307,000 deaths. Prostate cancer occur more frequently in the western countries or developed world, but incidence rates have been continuously arising in the developing countries. Clinical detection increased significantly in the 1980s and 1990s in the global range due to development of the gold standard--PSA testing. Studies of males who died from unrelated causes have found prostate cancer in 30% to 70% of those over the age of 60.
Most hormone-naive prostate cancers become resistant to treatments after 1-3 years and resume growth despite hormone therapy, a condition termed as "hormone-refractory prostate cancer" (HRPC) or "castration-resistant prostate cancer (CRPC)". The most prevalent chemotherapeutic agent docetaxel (Taxotere) has been used as a standardized modality for CRPC and provides a median survival benefit of 2-3 months. A second-line chemotherapy involves cabazitaxel. Although combination of bevacizumab, docetaxel, thalidomide and prednisone appears effective in the treatment of CRPC, these agents are usually used after the occurrence of CRPC, not before. Thus, whether or not these patients should receive chemotherapy prior to development of CRPC, and whether this approach can prevent the aggressive progression of the disease to a treatment refractory status, remain largely open but intriguing questions.
In this study, investigators performed a Phase I, single agent exploration, multicenter clinical trial to establish the treatment efficacy of several chemotherapeutic agents in patients with high risk localized prostate cancer who have developed the primary cancer in prostate. Up to 5 cohorts have been enrolled to determine the effectiveness and safety of single therapeutic strategy. Besides the five-year disease-free survival, overall survival and five-year metastasis-free survival post treatment, investigators also take into account the anticancer agent-induced tumor stroma damage extent, which may provide further evidence to support the treatment efficacy and assess the potential influence of a damaged tumor microenvironment on disease progression or regression in clinical settings.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 300 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Shanghai Jiao Tong University School of Medicine is the lead sponsor of 374 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin
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.
As preoperative neoadjuvant chemotherapy, drugss including Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin (CDMS) will be administered 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.
Also known as: Jevtana, Taxotere, Novantrone, JM216.
5 years disease-free survival
There is no disease-associated progression during the 5 years post treatment (chemotherapy plus surgery).
Time frame: 5 years
5 years overall survival and metastasis-free survival
The overall survival status and distant metastasis-free survival status during the 5 years post treatment (chemotherapy plus surgery).
Time frame: 5 years
Plan to share: No — Investigators are happy to make individual participant data (IPD) available to other researchers upon request, as long as the data are not confidential and not restrained by the ethics policy.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shanghai Jiao Tong University School of Medicine →