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Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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
Conditions
Interventions
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.
Abiraterone Acetate
1000 mg (250 mg×4 tablets) once daily, orally
Prednisolone tablets
5 mg once daily, orally.
Enzalutamide
160 mg (40 mg× 4 tablets) once daily, orally.
Apalutamide
240 mg (60 mg×4 tablets) once daily, orally.
Darotamide
600 mg (300 mg × 2 tablets) twice daily, orally.
Rezvilutamide
240 mg (80 mg × 3 tablets) once daily orally
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.
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