RecruitingNot ApplicableNCT06864533

Adjuvant Chemotherapy for High Malignant Prostate Cancer

Evaluation of Chemotherapy With Adjuvant Docetaxel After Radiotherapy for Localized High Malignant Prostate Cancer: A Prospective Muti-center Non-Randomized Controlled Trial


Sponsor

Peking University First Hospital

Enrollment

315 participants

Start Date

Sep 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to evaluate the efficacy of adjuvant docetaxel chemotherapy following radical radiotherapy in patients with localized high-grade prostate cancer. Eligible participants include those diagnosed with prostate cancer confirmed by biopsy or surgical pathology, with a Gleason score of 9-10 or containing a Gleason 5 component, and no evidence of distant metastasis. Patients will be divided into two groups: the standard treatment group receiving only radical treatment (radiotherapy or surgery), and the standard treatment plus chemotherapy group, receiving four to six cycles of docetaxel chemotherapy after standard treatment. The primary endpoint is Failure-Free Survival (FFS), with secondary endpoints including Biochemical Relapse-Free Survival (BRFS), Metastasis-Free Survival (MFS), Overall Survival (OS), and assessment of adverse events The study aims to better understand the impact of adjuvant chemotherapy on the prognosis of patients with high-risk prostate cancer and determine whether it improves survival outcomes.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding chemotherapy after standard treatment (surgery or radiation) can improve outcomes for men with very aggressive prostate cancer (Gleason grade 9-10). **You may be eligible if...** - You have been diagnosed with highly aggressive prostate cancer (Gleason score 9-10) confirmed by biopsy or surgery - Your cancer has not spread to distant parts of the body - You are planning to receive or have received standard treatment like surgery or radiation - You are in good enough health to handle chemotherapy **You may NOT be eligible if...** - Your cancer has already spread to other organs or bones - You have already received chemotherapy or hormone therapy for prostate cancer - You have serious heart, liver, or kidney problems - You are on blood thinners that cannot be safely stopped 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

DRUGDocetaxel

Chemotherapy will start 4-8 weeks after the completion of radiotherapy. The chemotherapy regimen will consist of docetaxel 75 mg/m² administered intravenously on Day 1, repeated every 21 days for a total of 4-6 cycles. In cases of significant neuroendocrine differentiation and if well-tolerated, a combination of docetaxel and carboplatin (docetaxel 75 mg/m² and carboplatin AUC 4-6) will be used. Pre-treatment with dexamethasone will be administered to reduce potential side effects.


Locations(2)

Peking University First Hospital

Beijing, Beijing Municipality, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

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NCT06864533


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