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

NCT05406999 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2022-08-16

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2026-12-31
Completion
2030-06-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05406999 on ClinicalTrials.gov