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Neoadjuvant Therapy of Abiraterone Plus ADT for High Risk Prostate Cancer

NCT04356430 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-12-16

No results posted yet for this study

Summary

High risk prostate cancer (PCa) had worse outcomes on radical treatment results, short-time oncological results, even cancer-specific survival, than those low or mediate risk PCa. Neoadjuvant treatment before radical prostatectomy had been proven to get some benefits on peri-operation results, especially on reduction of tumor volume and minimization of biochemical recurrence. This study will evaluate the efficacy and safety of androgen deprivation therapy (ADT) with abiraterone in neoadjuvant therapy for surgically resectable high-risk or very high-risk PCa.

Conditions

Interventions

DRUG

Abiraterone Acetate

1000 mg orally daily for 24 weeks before robotic assisted radical prostatectomy

DRUG

Prednisone

5 mg oral low dose prednisone, once daily

DRUG

Goserelin 10.8 mg

10.8 mg goserelin hypodermic once per 12 weeks

Sponsors & Collaborators

  • 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
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2021-03-01
Completion
2023-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
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 NCT04356430 on ClinicalTrials.gov