Adjuvant Chemotherapy for High Malignant Prostate Cancer

NCT06864533 | Recruiting DMC

• 1 other identifier: PKUFH-GS5
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostate Cancer; Radiation Therapy; Chemotherapy; Gleason Score

Outcome Measures

Primary Outcomes (1)

• Failure-Free Survivall，FFS

  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.

  5 years

Secondary Outcomes (4)

• Biochemical relapse-free survival，BRFS

  5 years

• Metastasis-free survival, MFS

  5 years

• Overall survival, OS

  5 years

• Toxicities

  5 years

Study Arms (2)

Standard Treatment Plus Chemotherapy Group

EXPERIMENTAL

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.

Drug: Docetaxel

Standard Treatment Group

NO INTERVENTION

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.

Interventions

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.

Also known as: carboplatin

Standard Treatment Plus Chemotherapy Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\^

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Peking University Shenzhen Hospital: collaborator

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Carboplatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: September 1, 2019
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2031
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)