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Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer

NCT06575257 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-08-28

No results posted yet for this study

Summary

The purpose of this study is to determine if treatment with Darolutamide plus androgen deprivation therapy (ADT) before radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and pathological tumor volume with minimal residual disease (MRD)) as compared to ADT.

Conditions

Interventions

DRUG

Darolutamide

600 mg orally twice daily for 12 weeks before radical prostatectomy

DRUG

Goserelin 3.6 mg

3.6 mg goserelin hypodermic once per 4 weeks

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Principal Investigators

  • Weijun Qin, MD · The First Affillated Hospital, the Air Force Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2026-05-31
Completion
2029-05-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT06575257 on ClinicalTrials.gov