Adjuvant Chemotherapy for High Malignant Prostate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-80
SponsorPeking University First Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients who was histologically confirmed prostate cancer diagnosed by biopsy or surgery with a Gleason score of 9-10 (GG grade 5) or containing Gleason 5 components with no evidence of distant metastasis.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Docetaxel
DrugChemotherapy 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 groups
315 Participants
are divided into 2 treatment groupsGroup A: Standard Treatment Plus Chemotherapy Group1 intervention
Group B: Standard Treatment Group0 interventions
Trial outcomes
Primary outcomes
1
Failure-Free Survivall，FFS
The time from radiotherapy to the first occurrence of any of the following events: biochemical recurrence, systemic treatment modification due to confirmed consecutive PSA elevation, radiographic distant metastasis, or death from any cause, whichever occurred first.
Time frame
5 yearsSecondary outcomes
1
Biochemical relapse-free survival，BRFS
The time from radiotherapy to the first occurrence of biochemical relapse (defined as PSA rise meeting the criteria for biochemical recurrence)
Time frame
5 years2
Metastasis-free survival, MFS
The time from radiotherapy to the first occurrence of distant metastasis.
Time frame
5 years3
Overall survival, OS
The time from radiotherapy to the first occurrence of death.
Time frame
5 years4
Toxicities
The assessment of adverse events will be conducted using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking University First Hospital
Lead sponsor
Peking University Shenzhen Hospital
Collaborator
Source ClinicalTrials.gov