ArticleFuture science OA2025
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.
Article in Future science OA, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundProstate 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.
methodsThis 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).
resultsThe 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%;
conclusionFK-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.
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