Clinical trial NCT06864533: Adjuvant Chemotherapy for High Malignant Prostate Cancer
Official title: Evaluation of Chemotherapy With Adjuvant Docetaxel After Radiotherapy for Localized High Malignant Prostate Cancer: A Prospective Muti-center Non-Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Radiation Therapy
Chemotherapy
Gleason Score
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Shenzhen Hospital
First posted: 2025-03-07
Enrollment: 315
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Failure-Free Survivall，FFS
timeFrame: 5 years
Secondary outcomes:
measure: Biochemical relapse-free survival，BRFS
timeFrame: 5 years
measure: Metastasis-free survival, MFS
timeFrame: 5 years
measure: Overall survival, OS
timeFrame: 5 years
measure: Toxicities
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
Study officials:
References: