Evaluation of triplet therapy combined with robot-assisted cytoreductive prostatectomy for high-volume metastatic prostate cancer: a multicentre randomised controlled trial protocol.
This study is investigating whether combining triplet therapy with surgery can improve outcomes for patients with high-volume metastatic prostate cancer.
Where it sits
this study against the rest of the triptorelin corpusSummary and findings
This study evaluates the efficacy of triplet therapy combined with robot-assisted cytoreductive prostatectomy in patients with high-volume metastatic prostate cancer. Patients will receive triptorelin 15 mg every 3 months along with chemotherapy and an androgen receptor pathway inhibitor. The primary endpoints include progression-free survival and the 1-year progression-free survival rate.
Abstract
<h4>Background</h4>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.<h4>Study design</h4>This is an open-label, prospective, two-arm, multicentre, randomised controlled trial.<h4>Endpoints</h4>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).<h4>Patients and methods</h4>Patients aged 18-75 years with high-volume mPCa will receive ADT (triptorelin 15 mg every 3 months), four-six cycles of chemotherapy (docetaxel 75 mg/m<sup>2</sup> 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.<h4>Trial registration</h4>Chinese Clinical Trial Registry: ChiCTR2600121819.
Background
This paper addresses the clinical question of the effectiveness of combining triplet therapy with local surgery in high-volume metastatic prostate cancer patients. Previous studies have indicated that triplet therapy can alleviate symptoms and reduce disease progression, but the role of local surgery in this context remains unclear. This study aims to fill that gap by investigating the potential benefits of robot-assisted cytoreductive prostatectomy in conjunction with triplet therapy.
Methods
This is an open-label, prospective, two-arm, multicentre, randomised controlled trial. A total of 88 patients aged 18-75 years with high-volume metastatic prostate cancer will be enrolled. Participants will receive triptorelin 15 mg every 3 months, docetaxel chemotherapy, and an androgen receptor pathway inhibitor. The primary endpoints include progression-free survival and the 1-year progression-free survival rate.
Results
Not reported in abstract.
Interpretation
The study's design aims to provide insights into the effectiveness of combining surgery with triplet therapy, but the open-label nature and small sample size may introduce biases. The primary endpoints focus on progression-free survival, which is a surrogate endpoint and may not fully capture clinical outcomes. The implications for practice will depend on the results of this trial and how they compare to existing literature on treatment for high-volume metastatic prostate cancer.
Key findings
- 88 eligible patients will be randomised in a 1:1 ratio.
- Patients aged 18-75 years with high-volume metastatic prostate cancer will be included.
- The control group will continue treatment with triptorelin and rezvilutamide.
- The experimental group will receive robot-assisted cytoreductive prostatectomy in addition to triptorelin and rezvilutamide.
Limitations
- open-label design may introduce bias
- small sample size of 88 patients
- no long-term outcomes reported
- surrogate endpoints used for primary outcomes