Editor’s Note: Radical prostatectomy (RP) remains the primary surgical treatment for localized prostate cancer. However, a substantial proportion of patients experience biochemical recurrence (BCR) following surgery, which is closely associated with disease progression and prostate cancer–specific mortality. Consequently, reducing postoperative BCR and improving long-term outcomes in prostate cancer patients have become major areas of clinical research focus.
Recently, results from the ARES study—a prospective, single-arm, multicenter clinical trial initiated by Professor Guo Hongqian from the Department of Urology, Nanjing Drum Tower Hospital affiliated with Nanjing University School of Medicine—were selected for presentation at ESMO Asia. This study evaluated adjuvant androgen deprivation therapy (ADT) combined with apalutamide in patients at high risk of recurrence after radical prostatectomy, offering a novel therapeutic option for this challenging population.
On this occasion, Urology Frontier invited Xi Zheng, representing the Nanjing Drum Tower Hospital research team, to share the efficacy and safety data from the ARES study and discuss its future prospects.
Urology Frontier
Q: What are the current diagnostic and therapeutic challenges faced by patients at high risk of recurrence after radical prostatectomy?
Professor Zheng Xi:
Radical prostatectomy is the standard treatment for localized prostate cancer. However, previous studies have shown that among high-risk patients with a CAPRA-S score ≥6, the 5-year biochemical progression-free survival (bPFS) rate is only 29.3%, compared with as high as 91.4% in low-risk patients. These data clearly indicate that patients at high risk of recurrence after RP face substantial challenges, including a high likelihood of postoperative recurrence and poor long-term prognosis.
Although adjuvant therapy after surgery can reduce the risk of recurrence, the efficacy of traditional ADT alone remains limited. Therefore, identifying effective strategies to further lower recurrence risk and improve outcomes in this high-risk population is a major unmet clinical need. The ARES study was initiated precisely in this context, with the goal of exploring more effective postoperative treatment strategies and improving the overall management of high-risk prostate cancer patients.
Urology Frontier
Q: You presented the ARES study results at the conference on behalf of the research team. What key findings have been achieved so far, and how would you assess the safety profile?
Professor Zheng Xi:
The ARES study is a multicenter, prospective, single-arm phase II clinical trial designed to evaluate the efficacy and safety of apalutamide in combination with ADT in patients at high risk of recurrence after radical prostatectomy. A total of 103 patients with localized prostate cancer and a CAPRA-S score ≥6 were enrolled.
In terms of efficacy, the 6-month interim analysis demonstrated that all patients achieved undetectable PSA levels (<0.1 ng/mL), with a 6-month bPFS rate of 100%. These results indicate that the combination of apalutamide and ADT provides robust short-term disease control, effectively suppressing PSA levels and preventing biochemical recurrence.
Regarding safety, the regimen was well tolerated, and no patients required dose modification. These preliminary findings suggest that apalutamide combined with ADT offers both favorable efficacy and a manageable safety profile for the prevention of postoperative biochemical recurrence in patients with high-risk localized prostate cancer. Of course, patient follow-up is ongoing, and longer-term data will be reported in the future.
Urology Frontier
Q: What is the particular significance of these findings for prostate cancer patients in China, and how might they contribute to improving the overall continuum of prostate cancer care?
Professor Zheng Xi:
The ARES study is the first investigator-initiated trial (IIT) of apalutamide conducted in China. First and foremost, it provides a new therapeutic option for Chinese patients with high-risk prostate cancer. The encouraging preliminary efficacy and safety data of apalutamide combined with ADT offer clinicians an evidence-based alternative when selecting postoperative adjuvant treatment strategies for high-risk patients.
Under the leadership of Director Guo Hongqian, the Department of Urology at Nanjing Drum Tower Hospital places strong emphasis on clinical research. We have established a dedicated subspecialty research team, with Professor Zhang Shun serving as a full-time investigator responsible for coordinating and advancing all clinical trials. To date, we have led eight studies and participated in 184 domestic and international multicenter clinical trials, successfully passing regulatory inspections by the National Medical Products Administration for four consecutive years.
Our research portfolio spans both industry-sponsored trials (ISTs) and investigator-initiated trials (IITs), with notable achievements across both categories. In addition to the ARES study focused on postoperative adjuvant therapy, we have also conducted a prospective, multicenter cohort study evaluating treatment strategies for patients with biochemical recurrence after radical prostatectomy, as well as the PROact study investigating the early use of PARP inhibitors in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The results of these studies have been presented at major international conferences, including ASCO, ESMO, EAU, and AUA.
Through continuous research-driven clinical innovation, we aim to advance clinical practice and ultimately improve the overall standard of prostate cancer treatment in China.
Professor Zheng Xi
