A Phase I Study of Neoadjuvant Chemotherapy Involving Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin (CDMS) Followed by Surgery for Patients With High Risk Localized Prostate Cancer
Who is this study for? Older adult male patients with Prostate Cancer
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:
• 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 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.
Locations
Other Locations
China
Qilu Hospital of Shandong University
RECRUITING
Qingdao
Zhongshan Hospital
RECRUITING
Shanghai
Contact Information
Primary
Yu Sun, Ph.D
sunyu@sibs.ac.cn
86-21-54923302
Backup
Weijun Ma, Ph.D
wjma@sibs.ac.cn
86-21-54923268
Time Frame
Start Date:2015-01
Estimated Completion Date:2027-12
Participants
Target number of participants:50
Treatments
Experimental: CDMS, Surgery
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.
No_intervention: Control
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.