NCT06864533Recruiting
Adjuvant Chemotherapy for High Malignant Prostate Cancer
Evaluation of Chemotherapy With Adjuvant Docetaxel After Radiotherapy for Localized High Malignant Prostate Cancer: A Prospective Muti-center Non-Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 315 (estimated)
- First submitted
- 3 Mar 2025
- Start date
- 1 Sept 2019
- Primary completion date
- 1 Sept 2025
- Lead sponsor
- Peking University First Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT06864533
What you commit to
- Study type: Observational
- Planned participants: 315
- From 1 Sept 2019 to the primary completion date, 1 Sept 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous abdominal radiation therapy.
- Pre-existing or concomitant bleeding disorders.
Other illness
- History of malignant tumors (except those cured for more than 5 years).
- Active infections.
- 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.
Other
- Weight loss \> 10% within the past 6 months.
Who the study is looking for
- 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.
- Karnofsky Performance Status (KPS) ≥ 80.
- Adequate blood count: white blood cell ≥ 3.5 × 10\^9/L, neutrophils ≥ 1.5 × 10\^9/L, platelets ≥ 100.0 × 10\^
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hebei Yi Zhou Cancer Hospital Coordinator of this site? Confirm its status | Baoding | China | Recruiting |
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Peking University Shenzhen Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.