Junco J1, Fuentes F1, Rodríguez R, Calzada L1, Baladrón I2, Pimentel E1, Basulto R1, Reyes O2, Garay H2 and Guillén G2
Posters-Accepted Abstracts: J Cancer Sci Ther
GnRH-based vaccines represent a promising anti-hormonal treatment alternative in prostate cancer, because they can reduce serum testosterone to cast rating levels, avoid the ??hot flushes? produced by GnRH analogues and can be administered in acute and complicated forms of prostate cancer. The present study assesses the application of Heber provac, a GnRH based vaccine candidate for patients suffering from advanced prostate cancer. The main objective of the clinical trial was to evaluate the safety and efficacy of this vaccine candidate in 4 levels of dosage. To this aim, 56 patients affected by advanced prostate cancer diagnosed by biopsy were included. As result, after the first immunizations, the patients exhibited anti GnRH antibodies and in turn, testosterone levels reduction. In concordance with the hormonal and immunological response, the patients exhibit a decrease of both; the number of obstructive symptoms as well as the severity of them. There was also a normalization of the prostatic specific antigen (PSA) in the 80% of the patients after they finished the last immunization and the clinical evaluation demonstrated the significant reduction of the primary tumor from grades III/IV to I/II in all the patients that respond biochemically. Regarding the safety, majority of adverse effects of the vaccine were those expected according to the mechanism of action of the vaccine through the reduction of testosterone levels. No severe adverse events were found in any of the patients. Only the 4.4% of the adverse effects were grade III. We conclude that the vaccine proved to be safe and effective in the 4 dose levels. In order to a new clinical trial in a major number of patients is currently planned.
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