A Randomised Trial of Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin (CDMS) Plus Surgery for Prostate Cancer Patients

NCT03258320 | Recruiting Phase 2 DMC

• 1 other identifier: PCA-81472709
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostate Cancer Patients

Keywords

Cabazitaxel; Docetaxel; Mitoxantrone; Satraplatin; Surgery; Prostate Cancer; Localized; High Risk

Outcome Measures

Primary Outcomes (1)

• 5 years disease-free survival

  There is no disease-associated progression during the 5 years post treatment (chemotherapy plus surgery).

  5 years

Secondary Outcomes (1)

• 5 years overall survival and metastasis-free survival

  5 years

Study Arms (2)

CDMS, Surgery

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin DRUG

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.

CDMS, Surgery

Eligibility Criteria

• Age: 40 Years - 75 Years
• Gender Eligibility Details: All participant patients should be male, adult.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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.

You may not qualify if:

• age ≥ 76
• severe major organ dysfunction
• WHO performance status of \>1
• prior cancer chemotherapy
• Stage IV.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Fudan University: collaborator
• Qilu Hospital of Shandong University: collaborator

Study Sites (2)

Qilu Hospital of Shandong University

Qingdao, Shandong, 266035, China

RECRUITING

Zhongshan Hospital

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

cabazitaxel; Docetaxel; Mitoxantrone; satraplatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Quinones; Polycyclic Compounds

Study Officials

• Yu Sun, Ph.D

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Sun, Ph.D

CONTACT

86-21-54923302; sunyu@sibs.ac.cn

Weijun Ma, Ph.D

CONTACT

86-21-54923268; wjma@sibs.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Both the participants and care providers will be blind to the agents, but the investigators will be aware of and keep track of the whole regime and agents.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Chemotherapy (single agent of CDMS) will be performed 45 days before surgery for patients who are diagnosed with prostate cancer without severe distant metastasis. The chemotherapy using CDMS will be done for 4 cycles within 30 days after first diagnosis of prostate cancer.

Study Record Dates

• First Submitted: August 20, 2017
• First Posted: August 23, 2017
• Study Start: January 1, 2015
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)