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Recruiting NCT06864533

Adjuvant Chemotherapy for High Malignant Prostate Cancer

— Observational Prostate Cancer Radiation Therapy Chemotherapy Gleason Score

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Docetaxel.
Who it may be relevant to
Registry conditions: Prostate Cancer, Radiation Therapy, Chemotherapy, Gleason Score. Basic parameters: 18 years — 80 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Evaluation of Chemotherapy With Adjuvant Docetaxel After Radiotherapy for Localized High Malignant Prostate Cancer: A Prospective Muti-center Non-Randomized Controlled Trial

Overview

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.

Interventions

  • Drug Docetaxel
    Chemotherapy will start 4-8 weeks after the completion of radiotherapy. The chemotherapy regimen will consist of docetaxel 75 mg/m² administered intravenously on Day 1, repeated every 21 days for a total of 4-6 cycles. In cases of significant neuroendocrine differentiation and if well-tolerated, a combination of docetaxel and carboplatin (docetaxel 75 mg/m² and carboplatin AUC 4-6) will be used. Pre-treatment with dexamethasone will be administered to reduce potential side effects.

Primary outcome measures

  • Failure-Free Survivall，FFS [Time frame: 5 years]
Secondary outcome measures (4)
  • Biochemical relapse-free survival，BRFS [Time frame: 5 years]
  • Metastasis-free survival, MFS [Time frame: 5 years]
  • Overall survival, OS [Time frame: 5 years]
  • Toxicities [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • 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\^

Exclusion criteria

  • History of malignant tumors (except those cured for more than 5 years).
  • Previous abdominal radiation therapy.
  • Weight loss > 10% within the past 6 months.
  • Pre-existing or concomitant bleeding disorders.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 2 centers
  • Peking University First Hospital — Beijing
  • Peking University Shenzhen Hospital — Shenzhen

Identifiers

NCT: NCT06864533 · PKUFH-GS5

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗