Adjuvant chemotherapy for high-grade prostate cancer
Evaluation of Chemotherapy With Adjuvant Docetaxel After Radiotherapy for Localized High Malignant Prostate Cancer: A Prospective Muti-center Non-Randomized Controlled Trial
This study is testing if adding chemotherapy to standard treatment after radiation can help men with high-grade prostate cancer live longer without their cancer coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 315 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Male |
| Sponsor | Peking University First Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT06864533 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of adjuvant docetaxel chemotherapy following radical radiotherapy in patients with localized high-grade prostate cancer. Participants diagnosed with prostate cancer and a Gleason score of 9-10 will be divided into two groups: one receiving standard treatment and the other receiving standard treatment plus chemotherapy. The primary goal is to assess Failure-Free Survival (FFS), while secondary goals include Biochemical Relapse-Free Survival (BRFS), Metastasis-Free Survival (MFS), Overall Survival (OS), and monitoring adverse events. The study aims to enhance understanding of how adjuvant chemotherapy impacts the prognosis of high-risk prostate cancer patients.
Who should consider this trial
Good fit: Ideal candidates are adult males aged 18 and older with localized high-grade prostate cancer and a Gleason score of 9-10.
Not a fit: Patients with distant metastasis, significant cardiovascular disease, or a history of other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve survival rates and quality of life for patients with high-risk prostate cancer.
How similar studies have performed: Other studies have shown promising results with adjuvant chemotherapy in similar high-risk cancer populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.