Adjuvant Chemotherapy for High Malignant Prostate Cancer

Not Applicable

Recruiting

• Conditions: Prostate Cancer; Radiation Therapy; Chemotherapy; Gleason Score
• Interventions: Drug: Docetaxel

• Registration Number: NCT06864533
• Lead Sponsor: Peking University First Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-03
• Study First Posted: 2025-03-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-20
• Last Update Posted: 2025-04-24
• Primary Completion: 2026-09-01
• Study Completion: 2031-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 315

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Treatment Plus Chemotherapy Group	Docetaxel	This group will receive the standard radical treatment as in Arm 2, followed by adjuvant chemotherapy with 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.

Primary Outcome Measures

Name	Time	Method
Failure-Free Survivall，FFS	5 years	The time from radiotherapy to the first occurrence of any of the following events: biochemical relapse (defined as PSA rise meeting the criteria for biochemical recurrence), distant metastasis, or death.

Secondary Outcome Measures

Name	Time	Method
Biochemical relapse-free survival，BRFS	5 years	The time from radiotherapy to the first occurrence of biochemical relapse (defined as PSA rise meeting the criteria for biochemical recurrence)
Metastasis-free survival, MFS	5 years	The time from radiotherapy to the first occurrence of distant metastasis.
Overall survival, OS	5 years	The time from radiotherapy to the first occurrence of death.
Toxicities	5 years	The assessment of adverse events will be conducted using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Trial Locations

Locations (2)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

Peking University Shenzhen Hospital; 🇨🇳 Shenzhen, Guangdong, China