Long-term first-in-man phase I/II study of an adjuvant dendritic cell vaccine in patients with high-risk prostate cancer after radical prostatectomy
The Prostate Nov 17, 2021
Tryggestad AMA, Axcrona K, Axcrona U, et al. - A personalized dendritic cell (DC) vaccine to reduce the risk of biochemical relapse (BCR) was tested in patients with high-risk prostate cancer (PC) after radical prostatectomy, and findings of this adjuvant first-in-man phase I/II DC vaccine study demonstrated promising outcomes. Safety of the vaccine was evident, with no side effects.
BCR can occur despite surgery in high-risk PC cases, and noncurative disease can develop in these patients.
This study involved 20 patients with high-risk PC and undetectable PSA who underwent robot-assisted laparoscopic prostatectomy (RALP) and 12 weeks after this procedure they received DC vaccinations for 3 years or until BCR.
Of 20 patients, 11 remained BCR-free during a median of 96 months (range: 84–99), and BCR occurred in 9 patients, either during (n = 4) or after (n = 5) the vaccination period.
Early BCR during the vaccination period occurred in three of five patients diagnosed with intraductal carcinoma.
Remission after 84 months was achieved by five of the 12 patients with the International Society of Urological Pathology (ISUP) grade 5 PC, and all mounted immune responses.
A particularly high risk of developing postsurgical BCR was observed in patients diagnosed with extraprostatic extension and ISUP grade 5 PC.
In this subgroup, the vaccine response was associated with a decreased BCR incidence.
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