Actively Recruiting
Adjuvant Chemotherapy for High Malignant Prostate Cancer
Led by Peking University First Hospital · Updated on 2025-04-24
315
Participants Needed
2
Research Sites
626 weeks
Total Duration
On this page
Sponsors
P
Peking University First Hospital
Lead Sponsor
P
Peking University Shenzhen Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adjuvant Chemotherapy for High Malignant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed prostate cancer diagnosed by biopsy or surgery with a Gleason score of 9-10 (GG grade 5) or containing Gleason 5 components.
- No evidence of distant metastasis confirmed by imaging.
- Expected to receive standard radical treatment or postoperative radiotherapy.
- Estimated survival time greater than 12 months.
- Aged 18 years or older.
- Karnofsky Performance Status (KPS) 80 or higher.
- Adequate blood counts: white blood cells at least 3.5 x 10^9/L, neutrophils at least 1.5 x 10^9/L, platelets at least 100 x 10^9/L.
You will not qualify if you...
- History of malignant tumors except those cured for more than 5 years.
- Previous abdominal radiation therapy.
- Weight loss greater than 10% within the past 6 months.
- Pre-existing or current bleeding disorders.
- Active infections.
- Significant cardiovascular disease such as uncontrolled hypertension, unstable angina, congestive heart failure class II or higher, unstable arrhythmias, or peripheral vascular disease class II or higher.
- Any condition considered intolerable to chemotherapy by the oncology department.
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Trial Site Locations
Total: 2 locations
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
2
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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