Evaluating the Efficacy and Safety of Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
To evaluate: The radiographic progression-free survival (rPFS) of metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with androgen deprivation therapy (ADT) + second-generation antiandrogens±chemotherapy combined with cytoreductive prostatectomy (CRP)
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Male aged ≥18 and ≤75;
• Histologically confirmed prostate adenocarcinoma;
• Evidence of metastasis confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histology;
• Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (visceral organ metastasis);
• Prostate cancer has not received local treatment (e.g., prostate radiotherapy, cryotherapy, etc.);
• The surgeon believes the prostate can be removed;
Locations
Other Locations
China
The First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Lixin Hua, M.D.
hlx5858@163.com
13072564303
Backup
Shangqian Wang, M.D.,PhD
wsq5501@126.com
13770561625
Time Frame
Start Date: 2016-01-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 200
Treatments
Experimental: Local treatment group
Triplet or doublet therapy followed by cytoreductive prostatectomy or brachytherapy
Active_comparator: SOC group
Triplet or doublet therapy (ie. docetaxel/abiraterone, apalutamide，Rezvilutamide，darolutamide，enzalutamide)
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University