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

PHASE2RecruitingINTERVENTIONAL
Enrollment

900

Participants

Timeline

Start Date

February 1, 2020

Primary Completion Date

December 31, 2026

Study Completion Date

June 30, 2030

Conditions
Neoadjuvant TherapyHigh Risk Prostate CancerLocally Advanced Prostate CancerIntense Endocrine Therapy
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.

Trial Locations (1)

210000

RECRUITING

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

All Listed Sponsors
lead

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

NCT05406999 - Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer | Biotech Hunter | Biotech Hunter