RecruitingPhase 2NCT05406999

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


Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

900 participants

Start Date

Feb 1, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving intensive hormone-blocking treatment before surgery (prostatectomy) can improve outcomes for men with high-risk or locally advanced prostate cancer. The idea is to shrink the cancer before removing it surgically. **You may be eligible if...** - You have been diagnosed with prostate cancer confirmed by biopsy - You are a candidate for radical prostatectomy (surgical removal of the prostate) - Your cancer meets high-risk criteria: tumor has spread beyond the prostate on imaging, Gleason score of 8 or higher, PSA level of 20 or higher, or lymph node involvement - You are in good physical condition (ECOG score 0 or 1) **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have poor kidney, liver, or blood function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGADT

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.

DRUGAbiraterone Acetate

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

DRUGPrednisolone tablets

5 mg once daily, orally.

DRUGEnzalutamide

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

DRUGApalutamide

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

DRUGDarotamide

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

DRUGRezvilutamide

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

DRUGPARP 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.

PROCEDURERobot-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

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NCT05406999


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