Reduced recurrence of prostate cancer with novel autologous cancer vaccine (FK- PC101) post-prostatectomy: long-term results from a single-center phase 1/2 study.

[BACKGROUND] Prostate cancer is a major contributor to cancer-related mortality in men. High-risk patients, particularly those with biochemical recurrence (BCR) following radical prostatectomy (RP), face poor long-term outcomes. Adjuvant options such as radiotherapy, chemotherapy, and androgen deprivation therapy (ADT) have shown limited benefit in this setting.

[METHODS] This retrospective analysis evaluated the safety, feasibility, and efficacy of FK-PC101, an autologous immunomodulated tumor cell vaccine, in high-risk post-RP patients. Data were drawn from the FK002-2001 trial, a phase 1/2, non-randomized, open-label study conducted in Brazil. A total of 62 patients were included: 23 in the vaccine group and 39 controls. Primary endpoints were safety and feasibility; secondary endpoints included biochemical recurrence-free survival (BRFS) and overall survival (OS).

[RESULTS] The vaccine was well tolerated, with most adverse events being grade 1-2 local reactions. PSA recurrence at 4 years was significantly lower in the vaccine group (11.8%) when compared to controls (36.8%;  = 0.0453). OS did not differ significantly between groups. A higher rate of erectile dysfunction was observed in the vaccine group ( = 0.047).

[CONCLUSION] FK-PC101 demonstrated safety and potential clinical benefit in reducing prostate specific antigen (PSA) recurrence after RP in high-risk prostate cancer patients. These findings support further evaluation in a randomized phase 2 trial.