NCT05406999

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study was designed to evaluate the efficacy and safety of different forms of neoadjuvant intense androgen deprivation therapy (ADT) compared with ADT alone, followed by prostatectomy.

Conditions

• Neoadjuvant Therapy
• High Risk Prostate Cancer
• Locally Advanced Prostate Cancer
• Intense Endocrine Therapy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-02-01
• Primary completion: 2026-12-31
• Completion: 2030-06-30
• First posted: 2022-06-07
• Last updated: 2022-08-16

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study