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
Year: 2025
Type: article
Abstract: 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%; P = 0.0453). OS did not differ significantly between groups. A higher rate of erectile dysfunction was observed in the vaccine group (P = 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.
Source: Future Science OA
Authors: D. M. O. Freitas, A. C. Stein, M. Berger, F. T. Kreutz
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,165
OpenAlex ID: W4413808856