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Efficacy and Safety of Darolutamide Combined With Docetaxel and ADT as Neoadjuvant Therapy for Locally Advanced Prostate Cancer.

NCT07730151 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-07-28

No results posted yet for this study

Summary

The goal of this study is to evaluate the efficacy and safety of darolutamide combined with docetaxel and ADT compared to docetaxel combined with ADT in treating locally advanced prostate cancer patients scheduled for radical prostatectomy. The participant population includes adult males with locally advanced prostate cancer (cT3b-cT4, N0, M0 or any cT, N1, M0). The main questions it aims to answer are:

Does the combination of darolutamide, docetaxel, and ADT improve treatment outcomes compared to docetaxel combined with ADT? What are the safety profiles and adverse effects associated with each treatment group? Researchers will compare the control group (docetaxel combined with ADT) to the experimental group (darolutamide combined with docetaxel and ADT) to see if the experimental treatment is more effective.

Participants will:

Receive either docetaxel combined with ADT or darolutamide combined with docetaxel and ADT for 4 cycles (16 weeks) as neoadjuvant treatment.

Undergo radical prostatectomy after completing the neoadjuvant treatment. Be followed up for 36 months post-surgery to assess treatment efficacy and safety.

Conditions

Interventions

DRUG

Darolutamide

Darolutamide: oral administration, 600 mg per dose, twice daily, taken with food.

DRUG

docetaxel

Docetaxel: intravenous injection, 75 mg/m², once every 3 weeks, for a total of 4 doses/cycles. (Oral prednisone acetate should be started 14 days before docetaxel chemotherapy at 5 mg twice daily and discontinued 3 weeks after the last chemotherapy cycle.)

DRUG

ADT

ADT: leuprorelin, goserelin, or triptorelin, selected by the investigator according to the patient's condition, administered by subcutaneous or intramuscular injection, using a once-monthly formulation uniformly.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • RenJi Hospital

    lead OTHER

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
2026-08-01
Primary Completion
2031-12-31
Completion
2031-12-31

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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 NCT07730151 on ClinicalTrials.gov