Actively Recruiting
Evaluation of Chemotherapy With Adjuvant Docetaxel After Radiotherapy for Localized High Malignant Prostate Cancer: A Prospective Multi-center Non-Randomized Controlled Trial
Led by Peking University First Hospital · Updated on 2025-04-24
315
Participants Needed
2
Research Sites
260 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 research aims to evaluate the effect of adding docetaxel chemotherapy after radical radiotherapy in patients with localized high-grade prostate cancer. Participants must have prostate cancer confirmed by biopsy or surgery with a Gleason score of 9-10 or containing Gleason 5 components, and no signs of distant spread. The goal is to understand if this additional chemotherapy improves survival outcomes compared to standard treatment alone. Participants will be divided into two groups. One group will receive standard radical treatment, including radiotherapy or surgery, and may also receive endocrine therapy as recommended. The other group will receive the same standard treatment followed by four to six cycles of intravenous docetaxel chemotherapy starting 4 to 8 weeks after radiotherapy. In some cases with significant neuroendocrine features, docetaxel combined with carboplatin may be given. Dexamethasone will be used before chemotherapy to reduce side effects. During the study, participants will be monitored for failure-free survival over five years, along with secondary measures such as biochemical relapse-free survival, metastasis-free survival, overall survival, and treatment-related toxicities. Regular assessments including imaging and blood tests will be conducted to check for cancer progression and safety. The trial is planned to continue until 2031, allowing long-term follow-up of outcomes and side effects.
CONDITIONS
Brief 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 or containing Gleason 5 components
- No evidence of distant metastasis confirmed by imaging
- Planned to receive standard radical treatment or postoperative radiotherapy
- Estimated survival time greater than 12 months
- Age 18 years or older
- Karnofsky Performance Status of 80 or higher
- Adequate blood counts: white blood cells ≥ 3.5 × 10^9/L, neutrophils ≥ 1.5 × 10^9/L, platelets ≥ 100 × 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 over 10% within the past 6 months
- Pre-existing or current bleeding disorders
- Active infections
- Significant cardiovascular disease or conditions considered intolerable to chemotherapy by oncology
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 to 18 weeks (4 to 6 cycles every 3 weeks)
Participants receive chemotherapy with docetaxel starting 4 to 8 weeks after completing radiotherapy. The chemotherapy regimen involves intravenous docetaxel 75 mg/m² on Day 1, repeated every 21 days for a total of 4 to 6 cycles. Some participants may also receive carboplatin depending on specific cancer characteristics and tolerability, with pre-treatment dexamethasone to reduce side effects.
1 visit every 3 weeks for chemotherapy administration
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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