Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Block
The current protocol will examine the use of a plasmid DNA vaccine encoding AR, alone or with T-cell checkpoint blockade, to induce and/or augment therapeutic T-cells following androgen deprivation in patients with newly diagnosed prostate cancer scheduled to undergo prostatectomy. Patients without evidence of metastat
| Condition(s) | Prostate Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | The current protocol will examine the use of a plasmid DNA vaccine encoding AR, alone or with T-cell checkpoint blockade, to induce and/or augment therapeutic T-cells following androgen deprivation in patients with newly diagnosed prostate cancer scheduled to undergo prostatectomy. Patients without evidence of metastatic disease, with tissue remaining from a pre-treatment biopsy, and who are being considered for standard treatment by prostatectomy, will be invited to participate and will be on study for up to 15 months. |
| Who can participate | Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate * Patients must be considered candidates for prostatectomy as per standard of care * High-risk patients for recurrent disease, with high risk defined based on one of the following criteria: * Gleason score 7 and baseline serum prostate specific antigen (PSA) \> 20 ng/mL * Gleason score \> 7 * Life expectancy of at least 12 months at screening * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate hematologic, renal and liver function as evidenced by the following within 4 weeks of day 1: * Absolute neutrophil count (ANC) \> 1000 / mm3 * HgB \> 9.0 gm/dL independent of transfusion * Platelets \> 100,000 / mm3 * Creatinine \< 2.0 mg/dL * Aspartate aminotransferase (AST), Alanine transa |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | University of Wisconsin, Madison |
| Locations | Madison, Wisconsin, United States |
| Start date | 2021-12-16 |
| NCT ID | NCT04989946 |
| Official listing | https://clinicaltrials.gov/study/NCT04989946 |