Adjuvant chemotherapy for high-grade prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting
• Peking University Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting
• Hebei Yi Zhou Cancer Hospital
  Baoding, Hebei, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.