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RECRUITING
NCT05406999
PHASE2

Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer

Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

View on ClinicalTrials.gov

Summary

This is a prospective, multicenter, multi-arm, non-randomized, open-label clinical trial to evaluate the efficacy and safety of neoadjuvant intense endocrine therapy for high-risk or locally advanced prostate cancer.

Official title: A Prospective, Multi-arm, Multi-center Clinical Trial on Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

900

Start Date

2020-02-01

Completion Date

2030-06-30

Last Updated

2022-08-16

Healthy Volunteers

No

Interventions

DRUG

ADT

The ADT regimen will be determined by the investigators at separate centers. The dose and frequency of administration will be consistent with the prescribing information. Available drugs include triptorelin, goserelin, leuprolide, digareke ect.

DRUG

Abiraterone Acetate

1000 mg (250 mg×4 tablets) once daily, orally

DRUG

Prednisolone tablets

5 mg once daily, orally.

DRUG

Enzalutamide

160 mg (40 mg× 4 tablets) once daily, orally.

DRUG

Apalutamide

240 mg (60 mg×4 tablets) once daily, orally.

DRUG

Darotamide

600 mg (300 mg × 2 tablets) twice daily, orally.

DRUG

Rezvilutamide

240 mg (80 mg × 3 tablets) once daily orally

DRUG

PARP inhibitor

The PARP inhibitors will be determined by the investigators at separate centers. The dosage and frequency of administration will be consistent with the prescribing information. Available drugs include olaparib, fluzoparib, pamiparib, talazoparib ect.

PROCEDURE

Robot-assisted radical prostatectomy

Robot-assisted radical prostatectomy was performed within 2 weeks after the end of the therapy.

Locations (1)

Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Nanjing, Jiangsu, China