NCT06864533 Adjuvant Chemotherapy for High Malignant Prostate Cancer
| NCT ID | NCT06864533 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University First Hospital |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 315 participants |
| Start Date | 2019-09-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 315 participants in total. It began in 2019-09-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Frequently Asked Questions
Who can join the NCT06864533 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 85 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06864533 currently recruiting?
Yes, NCT06864533 is actively recruiting participants. Visit ClinicalTrials.gov or contact Peking University First Hospital to inquire about joining.
Where is the NCT06864533 trial being conducted?
This trial is being conducted at Beijing, China, Shenzhen, China.
Who is sponsoring the NCT06864533 clinical trial?
NCT06864533 is sponsored by Peking University First Hospital. The trial plans to enroll 315 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.