Adjuvant Chemotherapy for High Malignant Prostate Cancer

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Mar 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of adding chemotherapy, specifically docetaxel, to the standard treatment for men with high-risk prostate cancer. The goal is to see if this combination can help patients live longer without their cancer coming back after they receive radiation therapy or surgery. Men eligible to participate in this trial must have a diagnosis of prostate cancer with a high Gleason score (which indicates aggressive cancer) and no signs that the cancer has spread to other parts of the body. They should also be expected to live for more than a year and be in good enough health to tolerate treatment.

Participants in the trial will be divided into two groups: one will receive just the standard treatment, while the other will get the standard treatment plus chemotherapy. This trial will track various outcomes, including how long patients stay cancer-free, any side effects they experience, and overall survival rates. If you're a man diagnosed with high-grade prostate cancer and meet the eligibility criteria, this study might provide you with an opportunity to explore a potentially beneficial treatment option.

Gender

MALE

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.