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NCT Number: NCT06864533

Adjuvant Chemotherapy for High Malignant Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Chemotherapy Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gleason Score Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Radiation Therapy Urogenital Diseases Urogenital Neoplasms

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

docetaxel

Drug

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.

Other names: carboplatin

Primary outcomes

  1. Failure-Free Survivall，FFS

    Time frame: 5 years

    The time from radiotherapy to the first occurrence of any of the following events: biochemical relapse (defined as PSA rise meeting the criteria for biochemical recurrence), distant metastasis, or death.

Secondary outcomes

  1. Biochemical relapse-free survival，BRFS

    Time frame: 5 years

    The time from radiotherapy to the first occurrence of biochemical relapse (defined as PSA rise meeting the criteria for biochemical recurrence)

  2. Metastasis-free survival, MFS

    Time frame: 5 years

    The time from radiotherapy to the first occurrence of distant metastasis.

  3. Overall survival, OS

    Time frame: 5 years

    The time from radiotherapy to the first occurrence of death.

  4. Toxicities

    Time frame: 5 years

    The assessment of adverse events will be conducted using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • Peking University Shenzhen Hospital

Registry information

Official study title

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

Acronym: PKUFH-GS5

Important dates

Study start
2019
Primary completion
2026
Study completion
2031
First posted
Mar 7, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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