Abstract | BACKGROUND: It is well known that the prognosis of castration-resistant prostate cancer (CRPC) is poor, and several immunotherapeutic strategies have been applied to the clinical trials. Research on immunotherapy has been of special interest for the treatment of CRPC for years. OBJECTIVE: DESIGN, SETTING, AND PARTICIPANTS: OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: PSA, progression-free survival (PFS), time to initiation of chemotherapy, and overall survival (OS) were analyzed using the Kaplan-Meier method, a log-rank test, and proportional hazard analysis. RESULTS AND LIMITATIONS: Overall, 37 patients received peptide vaccinations and 35 received dexamethasone alone. The primary end point was PSA PFS, which was significantly longer in the vaccination group than in the dexamethasone group (22.0 vs 7.0 mo; p=0.0076). Median OS was also significantly longer in the vaccination group (73.9 vs 34.9 mo; p=0.00084). The relatively small number of patients enrolled is the major limitation of the study. CONCLUSIONS: PPV immunotherapy was well tolerated and associated with longer PSA PFS and OS in men with chemotherapy-naive CRPC. A larger phase 3 study is needed to confirm our findings. PATIENT SUMMARY: TRIAL REGISTRATION: UMIN-CTR: 000000959.
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Authors | Kazuhiro Yoshimura, Takafumi Minami, Masahiro Nozawa, Takahiro Kimura, Shin Egawa, Hiroyuki Fujimoto, Akira Yamada, Kyogo Itoh, Hirotsugu Uemura |
Journal | European urology
(Eur Urol)
Vol. 70
Issue 1
Pg. 35-41
(07 2016)
ISSN: 1873-7560 [Electronic] Switzerland |
PMID | 26782346
(Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved. |
Chemical References |
- Antineoplastic Agents, Hormonal
- HLA-A Antigens
- HLA-A*02 antigen
- HLA-A*03 antigen
- HLA-A2 Antigen
- HLA-A24 Antigen
- HLA-A3 Antigen
- Vaccines, Subunit
- Dexamethasone
- Prostate-Specific Antigen
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Topics |
- Adenocarcinoma
(blood, therapy)
- Aged
- Antineoplastic Agents, Hormonal
(therapeutic use)
- Combined Modality Therapy
- Dexamethasone
(therapeutic use)
- Disease-Free Survival
- HLA-A Antigens
(immunology)
- HLA-A2 Antigen
(immunology)
- HLA-A24 Antigen
(immunology)
- HLA-A3 Antigen
(immunology)
- Humans
- Immunotherapy, Active
(methods)
- Male
- Middle Aged
- Precision Medicine
- Prostate-Specific Antigen
(blood)
- Prostatic Neoplasms, Castration-Resistant
(blood, therapy)
- Survival Rate
- Vaccines, Subunit
(therapeutic use)
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