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.
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).
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).
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.
K-PC101 is a novel autologous tumor cell vaccine for high-risk prostate cancer post-prostatectomy.The vaccine was safe and well tolerated, with mostly mild local reactions.PSA recurrence at 4 years was lower in vaccinated patients (11.8% vs. 36.8%).Immunologic responses may contribute to long-term disease control.Study limitations: retrospective design and baseline imbalances.Findings support further evaluation in a randomized phase 2 trial.
Future science OA. 2025 Aug 29 [Epub]
D M O Freitas, A C Stein, M Berger, F T Kreutz
Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil., FK-Biotecnologia S/A Brazil, Porto Alegre, Brazil., Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
PubMed http://www.ncbi.nlm.nih.gov/pubmed/40878915