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Prostate Cancer Treatment and Research / Prostate Cancer Diagnosis and Treatment / Advanced Radiotherapy Techniques · Journal article
British Journal of Urology · August 14, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a protocol document describing a planned multicentre RCT comparing triplet therapy (ADT, chemotherapy, ARPI) combined with robot-assisted cytoreductive prostatectomy versus triplet therapy alone in high-volume metastatic prostate cancer. No trial results are reported; the study design is sound but the protocol stage means no evidence of efficacy or safety is yet available.
Open-label, prospective, two-arm, multicentre randomised controlled trial. High-volume metastatic prostate cancer patients fit for docetaxel who achieve PSA ≤0.2 ng/mL after induction triplet therapy and are suitable surgical candidates.. Intervention: Robot-assisted cytoreductive prostatectomy combined with continuation of triptorelin and rezvilutamide.. Compared with: Continuation of triptorelin and rezvilutamide without surgery.. n = 88.
Primary endpoints are progression-free survival (PFS) and 1-year PFS rate Secondary endpoints include overall survival (OS) and health-related quality of life (HRQoL) Total 88 eligible patients will be randomised in 1:1 ratio
This is a protocol; no efficacy or safety results are reported.
This protocol documents a trial addressing an important clinical question about whether local surgery improves outcomes when added to systemic triplet therapy in advanced prostate cancer. Results will be clinically meaningful once the trial is completed and published; clinicians should await outcome data before changing practice.
This is a protocol for a planned RCT that has not yet reported results; it describes the design and rationale but presents no efficacy or safety data, making it a prospective study announcement rather than evidence of effectiveness.
As stated by the source record.
Quoted from the source exactly as published.
This protocol documents a trial addressing an important clinical question about whether local surgery improves outcomes when added to systemic triplet therapy in advanced prostate cancer. Results will be clinically meaningful once the trial is completed and published; clinicians should await outcome data before changing practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
BACKGROUND: Prostate cancer (PCa) is the second most common cancer in men. For patients with high-volume metastatic PCa (mPCa) who are fit for docetaxel, a triplet therapy regimen consisting of androgen deprivation therapy (ADT), chemotherapy, and an androgen receptor pathway inhibitor (ARPI) is recommended. Adding local radiotherapy to triplet therapy has been shown to alleviate symptoms and reduce disease progression. However, the benefit of combining triplet therapy with local surgery remains unclear and warrants further investigation in the present study. STUDY DESIGN: This is an open-label, prospective, two-arm, multicentre, randomised controlled trial. ENDPOINTS: Primary endpoints are progression-free survival (PFS) and the 1-year PFS rate. Disease progression is defined as prostate-specific antigen (PSA) progression, radiological progression, or unequivocal clinical progression. Secondary endpoints include overall survival (OS) and health-related quality of life (HRQoL). PATIENTS AND METHODS: every 3 weeks), and an ARPI (rezvilutamide 240 mg once daily). Patients achieving a PSA level ≤0.2 ng/mL and deemed suitable candidates for surgery will be enrolled. A total of 88 eligible patients will be randomised in a 1:1 ratio. The control group will continue treatment with triptorelin and rezvilutamide, while the experimental group will receive robot-assisted cytoreductive prostatectomy in addition to triptorelin and rezvilutamide. Baseline PSA levels will be recorded and re-examined at each chemotherapy cycle and every 3 months thereafter. Radiological evaluations will be performed every 6 months. Clinical progression will be assessed based on pain severity, performance status, and the need to initiate new anticancer therapy. HRQoL will be evaluated every 3 months. PFS and OS will be estimated using Kaplan-Meier curves and compared with the log-rank test. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2600121819.
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