RecruitingPhase 3NCT06177015

Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC

Randomized Controlled Study on the Efficacy and Safety of Intermittent Darolutamide Treatment in the Triple Therapy of Metastatic Hormone Sensitive Prostate Cancer


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

200 participants

Start Date

Dec 11, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the efficacy and safety of intermittent use of darolutamide compared to long-term use in combination with ADT and docetaxel in the treatment of mHSPC patients.


Eligibility

Sex: MALEMin Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing an intermittent dosing schedule for darolutamide — a hormone-blocking drug — when given alongside standard hormone therapy (ADT) and docetaxel chemotherapy for men with newly diagnosed metastatic hormone-sensitive prostate cancer (cancer that has spread but still responds to hormone lowering). **You may be eligible if...** - You are male, 18 or older, with a confirmed diagnosis of metastatic prostate cancer (spread to other parts of the body) - Your cancer is hormone-sensitive (has not yet become resistant to hormone therapy) - You are fit enough to receive ADT plus docetaxel chemotherapy - You have adequate bone marrow, kidney, and liver function **You may NOT be eligible if...** - Your prostate cancer has become castration-resistant (no longer responds to hormone lowering) - You have had prior treatments for metastatic disease - You have a serious heart condition or other illness that makes chemotherapy too risky - You are not willing or able to follow the study schedule 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

DRUGDarolutamide continuous

standard of care

DRUGDarolutamide intermittent

experimental group


Locations(1)

Urology dpt, First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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NCT06177015


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