Table 1.
Phase III trials to assess antitumour vaccines in patients with prostate cancer
| Antigen specificity | Vaccine type | Vaccine | Antigen | Combination agents | Patients enrolled | Study title | Results and/or comments | Refs. |
|---|---|---|---|---|---|---|---|---|
| Non-antigen specific | Cellular vaccines | GVAX | NA | NA | 626 | GVAX vaccine for prostate cancer versus docetaxel and prednisone in patients with metastatic hormone-refractory prostate cancer | Terminated (based on futility analysis showing that the chance of meeting the primary end point was <30%) | 38 |
| GVAX | NA | Docetaxel | 408 | Docetaxel in combination with GVAX immunotherapy versus docetaxel and prednisone in patients with prostate cancer | Terminated (accrual and treatment with GVAX stopped owing to IDMC recommendation) | 39 | ||
| Dendritic cell vaccines | DCVAC/PCa | NA | Docetaxel and prednisone | 1,182 | A randomized, double-blind, multicentre, parallel group, phase III study to evaluate efficacy and safety of DCVAC/PCa versus placebo in men with mCRPC eligible for first-line chemotherapy (VIABLE) | No improvement in overall survival of patients with mCRPC | 45 | |
| Antigen specific | Peptide vaccines | Personalized peptide vaccines | HLA-A24-restricted peptide epitopes from several proteins | NA | 306 | A randomized phase III trial of personalized peptide vaccination for CRPC progressing after docetaxel | No improvement in overall survival | 66 |
| Antigen-loaded dendritic cell or antigen-presenting cell vaccines | Sipuleucel-T | PAP | NA | 176 | PROvenge treatment and early cancer treatment | In randomized trials conducted in patients with recurrent prostate cancer after prostatectomy, no difference in time to biochemical failure was observed | 13,84 | |
| Sipuleucel-T | PAP | NA | 127 | Vaccine therapy in treating patients with metastatic prostate cancer that has not responded to hormone therapy | In a randomized trial, no evidence of increased time to progression was observed but prolonged overall survival was shown in patients receiving sipuleucel-T | 77 | ||
| Sipuleucel-T | PAP | NA | 512 | A randomized, double-blind, placebo-controlled phase III trial of immunotherapy with autologous antigen-presenting cells loaded with PA2024 (Provenge(R), APC8015) in men with metastatic androgen-independent prostatic adenocarcinoma | Prolonged overall survival in patients treated with the vaccine compared with patients receiving placebo led to FDA approval in 2010 | 13 | ||
| Viral, bacterial and fungal vaccines | PROSTVAC-VF/TRICOM | PSA | GM-CSF | 1,297 | Phase III trial of PROSTVAC in asymptomatic or minimally symptomatic patients with mCRPC | PROSTVAC was safe and well tolerated, but no improvement in overall survival was reported | 115 |
CRPC, castration-resistant prostate cancer; GM-CSF, granulocyte–macrophage colony-stimulating factor; IDMC, Independent Data Monitoring Committee; mCRPC, metastatic castration-resistant prostate cancer; NA, not available; PAP, prostatic acid phosphatase; PSA, prostate-specific antigen; TRICOM, B7-1, ICAM1 and leukocyte function-associated antigen 3.