Adjuvant Chemotherapy for High Malignant Prostate Cancer (PKUFH-GS5)

Peking University

Status: Enrolling

Conditions: Radiation Therapy; Chemotherapy; Gleason Score; Prostate Cancer

Treatments: Drug: Docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT06864533

PKUFH-GS5

Details and patient eligibility

About

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.

Enrollment: 315 estimated patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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315 participants in 2 patient groups

Standard Treatment Plus Chemotherapy Group

Experimental group

Description:

This group will receive the standard radical treatment as in Arm 2, followed by adjuvant chemotherapy with 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.

Treatment:

Drug: Docetaxel

Standard Treatment Group

No Intervention group

Description:

This group will receive the standard radical treatment for high-grade localized prostate cancer. Patients will undergo definitive or post operative radiotherapy. Endocrine therapy will be provided for high-risk patients as per NCCN guidelines, with a duration of 2 to 3 years with definitive radiotherapy . For postoperative patients, endocrine therapy will be given for salvage setting.