Adjuvant Chemotherapy for High Malignant Prostate Cancer

NCT06864533 · tracked via the Priya Life Science China tracker

Sponsor

Peking University First Hospital

Phase

Observational

Started

2019-09-01

Last updated

2026-08-20

Condition(s) studied

Prostate CancerRadiation TherapyChemotherapyGleason Score

Investigational drug(s) / intervention(s)

Docetaxel

Docetaxel: 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.

Study 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

MALE

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. Histologically confirmed prostate cancer diagnosed by biopsy or surgery with a Gleason score of 9-10 (GG grade 5) or containing Gleason 5 components. 2. No evidence of distant metastasis confirmed by imaging. 3. Expected to receive standard radical treatment or postoperative radiotherapy. 4. Estimated survival time greater than 12 months. 5. Aged ≥ 18 years. 6. Karnofsky Performance Status (KPS) ≥ 80. 7. Adequate blood count: white blood cell ≥ 3.5 × 10\^9/L, neutrophils ≥ 1.5 × 10\^9/L, platelets ≥ 100.0 × 10\^ Exclusion Criteria: 1. History of malignant tumors (except those cured for more than 5 years). 2. Previous abdominal radiation therapy. 3. Weight loss \> 10% within the past 6 months. 4. Pre-existing or concomitant bleeding disorders. 5. Active infections. 6. Significant cardiovascular disease (e.g., controlled hypertension, unstable angina, NYHA class ≥ II congestive heart failure, unstable symptomatic arrhythmias, or ≥ II peripheral vascular disease) or any condition deemed intolerable to chemotherapy by the oncology department.

Primary outcome measure(s)

Failure-Free Survivall，FFS — 5 years
The time from radiotherapy to the first occurrence of any of the following events: biochemical recurrence, systemic treatment modification due to confirmed consecutive PSA elevation, radiographic distant metastasis, or death from any cause, whichever occurred first.

Trial sites (3)

Facility	City	Region	Status
Peking University First Hospital	Beijing	Beijing Municipality	Recruiting
Peking University Shenzhen Hospital	Shenzhen	Guangdong	Recruiting
Hebei Yi Zhou Cancer Hospital	Baoding	Hebei	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06864533 on ClinicalTrials.gov ↗ ← All trials in China