biostudies-literatureUnknown66(7)Lilleby WThis study was supported by The Norwegian Research Council (FORNY program), Innovation Norway AS, Ultimovacs AS.In newly diagnosed metastatic hormone-naive prostate cancer (mPC), telomerase-based immunotherapy with the novel hTERT peptide vaccine UV1 can induce immune responses with potential clinical benefit. This phase I dose escalation study of UV1 evaluated safety, immune response, effects on prostate-specific antigen (PSA) levels, and preliminary clinical outcome. Twenty-two patients with newly diagnosed metastatic hormone-naïve PC (mPC) were enrolled; all had started androgen deprivation therapy and had no visceral metastases. Bone metastases were present in 17 (77%) patients and 16 (73%) patients had affected lymph nodes. Three dose levels of UV1 were given as intradermal injections combined with GM-CSF (Leukine^®). Twenty-one patients in the intention-to-treat population (95%) receCancer immunology, immunotherapy : CII891-901https://www.ebi.ac.uk/biostudies/studies/S-EPMC11028648biostudies-literaturePhase I/IIa clinical trial of a novel hTERT peptide vaccine in men with metastatic hormone-naive prostate cancer.PMC11028648Lilleby WInderberg EMMills KVlatkovic LHole KHGaudernack GBrunsvig PFSchulz MfalsePhase I/IIa clinical trial of a novel hTERT peptide vaccine in men with metastatic hormone-naive prostate cancer.In newly diagnosed metastatic hormone-naive prostate cancer (mPC), telomerase-based immunotherapy with the novel hTERT peptide vaccine UV1 can induce immune responses with potential clinical benefit. This phase I dose escalation study of UV1 evaluated safety, immune response, effects on prostate-specific antigen (PSA) levels, and preliminary clinical outcome. Twenty-two patients with newly diagnosed metastatic hormone-naïve PC (mPC) were enrolled; all had started androgen deprivation therapy and had no visceral metastases. Bone metastases were present in 17 (77%) patients and 16 (73%) patients had affected lymph nodes. Three dose levels of UV1 were given as intradermal injections combined with GM-CSF (Leukine^®). Twenty-one patients in the intention-to-treat population (95%) rece2017-01-01T00:00:00Z2017 Jul2026-06-02T01:42:44.631Z2026-04-13T03:12:17.806ZS-EPMC110286482839135710.1007/s00262-017-1994-y