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The Efficacy and Safety of Prostatectomy for Castration-Naive Oligometastatic Prostate Cancer

NCT04992026 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2024-12-05

No results posted yet for this study

Summary

This randomized, controlled, multi-center clinical trial aims to evaluate the efficacy and safety of prostatectomy for castration-Naive oligometastatic prostate cancer

Conditions

Interventions

PROCEDURE

robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection

Robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection will be performed.

DRUG

1.Abiraterone Acetate Tablets

1000mg(4 tablets, 250mg per tablet) daily for 6 cycles

DRUG

Prednisone Acetate Tablets

5 mg oral low dose prednisone taken along with Abiraterone Acetate Tablets

DRUG

Luteinizing Hormone-Releasing Hormone Analog

Hypodermic injection of Luteinizing Hormone-Releasing Hormone Analog every 4 weeks including goserelin, leuprolide, triptorelin ect.

Sponsors & Collaborators

  • The Affiliated Hospital of Xuzhou Medical University

    collaborator OTHER

  • The First People's Hospital of Changzhou

    collaborator OTHER

  • The First Affiliated Hospital of Soochow University

    collaborator OTHER

  • Wuxi People's Hospital

    collaborator OTHER

  • The Affiliated Hospital of Nantong University

    collaborator UNKNOWN

  • The Affiliated Hospital of Yangzhou University

    collaborator UNKNOWN

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    lead OTHER

Principal Investigators

  • Hongqian Guo, MD · Nanjing Drum Tower Hospital, affiliated to medical school of Nanjing University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2024-12-01
Completion
2024-12-02

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04992026 on ClinicalTrials.gov